Surgical systems for detecting end effector tissue distribution irregularities

ABSTRACT

A surgical stapling instrument includes an end effector that has a first jaw; a second jaw movable relative to the first jaw between an open configuration and a closed configuration to grasp tissue between the first jaw and the second jaw; an anvil; and a staple cartridge with staples deployable into the tissue and deformable by the anvil. The surgical stapling instrument further includes a control circuit configured to: determine tissue impedances at predetermined zones; detect an irregularity in tissue distribution within the end effector based on the tissue impedances; and adjust a closure parameter of the end effector in accordance with the irregularity.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of priority under 35 U.S.C. § 119(e)to U.S. Provisional Patent Application Ser. No. 62/691,227, titledCONTROLLING A SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSUREPARAMETERS, filed Jun. 28, 2018, the disclosure of which is hereinincorporated by reference in its entirety.

This application claims the benefit of priority under 35 U.S.C. § 119(e)to U.S. Provisional Patent Application Ser. No. 62/650,887, titledSURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES, filed Mar. 30,2018, to U.S. Provisional Patent Application Ser. No. 62/650,877, titledSURGICAL SMOKE EVACUATION SENSING AND CONTROLS, filed Mar. 30, 2018, toU.S.

Provisional Patent Application Ser. No. 62/650,882, titled SMOKEEVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, filed Mar. 30,2018, and to U.S. Provisional Patent Application Ser. No. 62/650,898,titled CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS,filed Mar. 30, 2018, the disclosure of each of which is hereinincorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/640,417,titled TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEMTHEREFOR, filed Mar. 8, 2018, and to Provisional Patent Application Ser.No. 62/640,415, titled ESTIMATING STATE OF ULTRASONIC END EFFECTOR ANDCONTROL SYSTEM THEREFOR, filed Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety.

This application also claims the benefit of priority under 35 U.S.C. §119(e) to U.S. Provisional Patent Application Ser. No. 62/611,341,titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017, to U.S.Provisional Patent Application Ser. No. 62/611,340, titled CLOUD-BASEDMEDICAL ANALYTICS, filed Dec. 28, 2017, and to U.S. Provisional PatentApplication Ser. No. 62/611,339, titled ROBOT ASSISTED SURGICALPLATFORM, filed Dec. 28, 2017, the disclosure of each of which is hereinincorporated by reference in its entirety.

BACKGROUND

The present disclosure relates to various surgical systems.

SUMMARY

In various aspects, a surgical stapling instrument comprising an endeffector is disclosed. The end effector comprises a first jaw and asecond jaw movable relative to the first jaw between an openconfiguration and a closed configuration to grasp tissue between thefirst jaw and the second jaw. The end effector further comprises ananvil and a staple cartridge. The staple cartridge comprises staplesdeployable into the tissue and deformable by the anvil. The surgicalstapling system further comprises a control circuit. The control circuitis configured to determine tissue impedances at predetermined zones,detect an irregularity in tissue distribution within the end effectorbased on the tissue impedances, and adjust a closure parameter of theend effector in accordance with the irregularity.

In various aspects, a surgical stapling instrument for stapling apreviously-stapled tissue is disclosed. The surgical stapling instrumentcomprises a shaft defining a longitudinal axis extending there through,and an end effector extending from the shaft. The end effector comprisesa first jaw and a second jaw movable relative to the first jaw betweenan open configuration and a closed configuration to grasp tissue betweenthe first jaw and the second jaw. The end effector further comprises ananvil and a staple cartridge. The staple cartridge comprises staplesdeployable into the previously-stapled tissue and deformable by theanvil. The end effector further comprises predetermined zones betweenthe anvil and the staple cartridge. The surgical stapling instrumentfurther comprises a circuit. The circuit is configured to measure tissueimpedances at the predetermined zones, compare the measured tissueimpedances to a predetermined tissue impedance signature of thepredetermined zones, and detect an irregularity in at least one ofposition and orientation of the previously-stapled tissue within the endeffector from the comparison.

In various aspects, a surgical stapling instrument comprising an endeffector is disclosed. The end effector comprises a first jaw and asecond jaw movable relative to the first jaw between an openconfiguration and a closed configuration to grasp tissue between thefirst jaw and the second jaw. The end effector further comprises ananvil and a staple cartridge. The staple cartridge comprises staplesdeployable into the tissue and deformable by the anvil. The end effectorfurther comprises predetermined zones between the anvil and the staplecartridge. The surgical stapling instrument further comprises a controlcircuit. The control circuit is configured to determine an electricalparameter of the tissue at each of the predetermined zones, detect anirregularity in tissue distribution within the end effector based on thedetermined electrical parameters, and adjust a closure parameter of theend effector in accordance with the irregularity.

FIGURES

The features of various aspects are set forth with particularity in theappended claims. The various aspects, however, both as to organizationand methods of operation, together with further objects and advantagesthereof, may best be understood by reference to the followingdescription, taken in conjunction with the accompanying drawings asfollows.

FIG. 1 is a block diagram of a computer-implemented interactive surgicalsystem, in accordance with at least one aspect of the presentdisclosure.

FIG. 2 is a surgical system being used to perform a surgical procedurein an operating room, in accordance with at least one aspect of thepresent disclosure.

FIG. 3 is a surgical hub paired with a visualization system, a roboticsystem, and an intelligent instrument, in accordance with at least oneaspect of the present disclosure.

FIG. 4 is a partial perspective view of a surgical hub enclosure, and ofa combo generator module slidably receivable in a drawer of the surgicalhub enclosure, in accordance with at least one aspect of the presentdisclosure.

FIG. 5 is a perspective view of a combo generator module with bipolar,ultrasonic, and monopolar contacts and a smoke evacuation component, inaccordance with at least one aspect of the present disclosure.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing configured to receivea plurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 7 illustrates a vertical modular housing configured to receive aplurality of modules, in accordance with at least one aspect of thepresent disclosure.

FIG. 8 illustrates a surgical data network comprising a modularcommunication hub configured to connect modular devices located in oneor more operating theaters of a healthcare facility, or any room in ahealthcare facility specially equipped for surgical operations, to thecloud, in accordance with at least one aspect of the present disclosure.

FIG. 9 illustrates a computer-implemented interactive surgical system,in accordance with at least one aspect of the present disclosure.

FIG. 10 illustrates a surgical hub comprising a plurality of modulescoupled to the modular control tower, in accordance with at least oneaspect of the present disclosure.

FIG. 11 illustrates one aspect of a Universal Serial Bus (USB) networkhub device, in accordance with at least one aspect of the presentdisclosure.

FIG. 12 illustrates a logic diagram of a control system of a surgicalinstrument or tool, in accordance with at least one aspect of thepresent disclosure.

FIG. 13 illustrates a control circuit configured to control aspects ofthe surgical instrument or tool, in accordance with at least one aspectof the present disclosure.

FIG. 14 illustrates a combinational logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 15 illustrates a sequential logic circuit configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of the present disclosure.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions, inaccordance with at least one aspect of the present disclosure.

FIG. 17 is a schematic diagram of a robotic surgical instrumentconfigured to operate a surgical tool described herein, in accordancewith at least one aspect of the present disclosure.

FIG. 18 illustrates a block diagram of a surgical instrument programmedto control the distal translation of a displacement member, inaccordance with at least one aspect of the present disclosure.

FIG. 19 is a schematic diagram of a surgical instrument configured tocontrol various functions, in accordance with at least one aspect of thepresent disclosure.

FIG. 20 is a stroke length graph showing an example of a control systemmodifying the stroke length of a clamping assembly based on thearticulation angle.

FIG. 21 is a closure tube assembly positioning graph showing an exampleof a control system modifying a longitudinal position of the closuretube assembly based on the articulation angle;

FIG. 22 is a comparison of a stapling method utilizing controlled tissuecompression versus a stapling method without controlled tissuecompression.

FIG. 23 is a force graph shown in section A and a related displacementgraph shown in section B, where the force graph and the displacementgraph have an x-axis defining time, a y-axis of the displacement graphdefines a travel displacement of a firing rod, and a y-axis of the forcegraph defines a sensed torsional force on a motor that is configured toadvance the firing rod.

FIG. 24 is a schematic illustration of a tissue contact circuit showingthe completion of the circuit upon contact with tissue a pair of spacedapart contact plates.

FIG. 25 is a perspective view of a surgical instrument that has aninterchangeable shaft assembly operably coupled thereto, in accordancewith at least one aspect of this disclosure.

FIG. 26 is an exploded assembly view of a portion of the surgicalinstrument of FIG. 25, in accordance with at least one aspect of thisdisclosure.

FIG. 27 is an exploded assembly view of portions of the interchangeableshaft assembly, in accordance with at least one aspect of thisdisclosure.

FIG. 28 is an exploded view of an end effector of the surgicalinstrument of FIG. 25, in accordance with at least one aspect of thisdisclosure.

FIG. 29A is a block diagram of a control circuit of the surgicalinstrument of FIG. 25 spanning two drawing sheets, in accordance with atleast one aspect of this disclosure.

FIG. 29B is a block diagram of a control circuit of the surgicalinstrument of FIG. 25 spanning two drawing sheets, in accordance with atleast one aspect of this disclosure.

FIG. 30 is a block diagram of the control circuit of the surgicalinstrument of FIG. 25 illustrating interfaces between the handleassembly, the power assembly, and the handle assembly and theinterchangeable shaft assembly, in accordance with at least one aspectof this disclosure.

FIG. 31 depicts an example medical device that can include one or moreaspects of the present disclosure.

FIG. 32 depicts an example end-effector of a medical device surroundingtissue in accordance with one or more aspects of the present disclosure.

FIG. 33 depicts an example end-effector of a medical device compressingtissue in accordance with one or more aspects of the present disclosure.

FIG. 34 depicts example forces exerted by an end-effector of a medicaldevice compressing tissue in accordance with one or more aspects of thepresent disclosure.

FIG. 35 also depicts example forces exerted by an end-effector of amedical device compressing tissue in accordance with one or more aspectsof the present disclosure.

FIG. 36 depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 37 also depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 38 also depicts an example tissue compression sensor system inaccordance with one or more aspects of the present disclosure.

FIG. 39 is also an example circuit diagram in accordance with one ormore aspects of the present disclosure.

FIG. 40 is also an example circuit diagram in accordance with one ormore aspects of the present disclosure.

FIG. 41 is graph depicting an example frequency modulation in accordancewith one or more aspects of the present disclosure.

FIG. 42 is graph depicting a compound RF signal in accordance with oneor more aspects of the present disclosure.

FIG. 43 is graph depicting filtered RF signals in accordance with one ormore aspects of the present disclosure.

FIG. 44 is a perspective view of a surgical instrument with anarticulable, interchangeable shaft.

FIG. 45 is a side view of the tip of the surgical instrument.

FIGS. 46 to 50 are graphs plotting gap size over time (FIG. 46), firingcurrent over time (FIG. 47), tissue compression over time (FIG. 48),anvil strain over time (FIG. 49), and trigger force over time (FIG. 50).

FIG. 51 is a graph plotting tissue displacement as a function of tissuecompression for normal tissues.

FIG. 52 is a graph plotting tissue displacement as a function of tissuecompression to distinguish normal and diseased tissues.

FIG. 53 illustrates one embodiment of an end effector comprising a firstsensor and a second sensor.

FIG. 54 is a logic diagram illustrating one embodiment of a process foradjusting the measurement of the first sensor based on input from thesecond sensor of the end effector illustrated in FIG. 53.

FIG. 55 is a logic diagram illustrating one embodiment of a process fordetermining a look-up table for a first sensor based on the input from asecond sensor.

FIG. 56 is a logic diagram illustrating one embodiment of a process forcalibrating a first sensor in response to an input from a second sensor.

FIG. 57 is a logic diagram illustrating one embodiment of a process fordetermining and displaying the thickness of a tissue section clampedbetween an anvil and a staple cartridge of an end effector.

FIG. 58 is a logic diagram illustrating one embodiment of a process fordetermining and displaying the thickness of a tissue section clampedbetween the anvil and the staple cartridge of the end effector.

FIG. 59 is a graph illustrating an adjusted Hall effect thicknessmeasurement compared to an unmodified Hall effect thickness measurement.

FIG. 60 illustrates one embodiment of an end effector comprising a firstsensor and a second sensor.

FIG. 61 illustrates one embodiment of an end effector comprising a firstsensor and a plurality of second sensors.

FIG. 62 is a logic diagram illustrating one embodiment of a process foradjusting a measurement of a first sensor in response to a plurality ofsecondary sensors.

FIG. 63 illustrates one embodiment of a circuit configured to convertsignals from a first sensor and a plurality of secondary sensors intodigital signals receivable by a processor.

FIG. 64 illustrates one embodiment of an end effector comprising aplurality of sensors.

FIG. 65 is a logic diagram illustrating one embodiment of a process fordetermining one or more tissue properties based on a plurality ofsensors.

FIG. 66 illustrates one embodiment of an end effector comprising aplurality of sensors coupled to a second jaw member.

FIG. 67 illustrates one embodiment of a staple cartridge comprising aplurality of sensors formed integrally therein.

FIG. 68 is a logic diagram illustrating one embodiment of a process fordetermining one or more parameters of a tissue section clamped within anend effector.

FIG. 69 illustrates one embodiment of an end effector comprising aplurality of redundant sensors.

FIG. 70 is a logic diagram illustrating one embodiment of a process forselecting the most reliable output from a plurality of redundantsensors.

FIG. 71 illustrates one embodiment of an end effector comprising asensor comprising a specific sampling rate to limit or eliminate falsesignals.

FIG. 72 is a logic diagram illustrating one embodiment of a process forgenerating a thickness measurement for a tissue section located betweenan anvil and a staple cartridge of an end effector.

FIGS. 73 and 74 illustrate one embodiment of an end effector comprisinga sensor for identifying staple cartridges of different types.

FIG. 75 illustrates one aspect of a segmented flexible circuitconfigured to fixedly attach to a jaw member of an end effector, inaccordance with at least one aspect of this disclosure.

FIG. 76 illustrates one aspect of a segmented flexible circuitconfigured to mount to a jaw member of an end effector, in accordancewith at least one aspect of this disclosure.

FIG. 77 illustrates one aspect of an end effector configured to measurea tissue gap GT, in accordance with at least one aspect of thisdisclosure.

FIG. 78 illustrates one aspect of an end effector comprising segmentedflexible circuit, in accordance with at least one aspect of this presentdisclosure.

FIG. 79 illustrates the end effector shown in FIG. 78 with the jawmember clamping tissue between the jaw member and the staple cartridge,in accordance with at least one aspect of this disclosure.

FIG. 80 is a diagram of an absolute positioning system of a surgicalinstrument where the absolute positioning system comprises a controlledmotor drive circuit arrangement comprising a sensor arrangement, inaccordance with at least one aspect of this disclosure.

FIG. 81 is a diagram of a position sensor comprising a magnetic rotaryabsolute positioning system, in accordance with at least one aspect ofthis disclosure.

FIG. 82 is a section view of an end effector of a surgical instrumentshowing a firing member stroke relative to tissue grasped within the endeffector, in accordance with at least one aspect of this disclosure.

FIG. 83 is a first graph of two closure force (FTC) plots depicting theforce applied to a closure member to close on thick and thin tissueduring a closure phase and a second graph of two firing force (FTF)plots depicting the force applied to a firing member to fire throughthick and thin tissue during a firing phase.

FIG. 84 is a graph of a control system configured to provide progressiveclosure of a closure member during a firing stroke when the firingmember advances distally and couples into a clamp arm to lower theclosure force load on the closure member at a desired rate and decreasethe firing force load on the firing member, in accordance with at leastone aspect of this disclosure.

FIG. 85 illustrates a proportional-integral-derivative (PID) controllerfeedback control system, in accordance with at least one aspect of thisdisclosure.

FIG. 86 is a logic flow diagram depicting a process of a control programor a logic configuration for determining the velocity of a closuremember, in accordance with at least one aspect of this disclosure.

FIG. 87 is a timeline depicting situational awareness of a surgical hub,in accordance with at least one aspect of the present disclosure.

FIG. 88 illustrates a perspective view of an end effector of a curvedsurgical stapling and cutting instrument including predetermined zones,in accordance with at least one aspect of the present disclosure.

FIG. 89 illustrates a straightened partial cross-sectional of the endeffector of the curved surgical stapling and cutting instrument of FIG.88 with tissue grasped by the end effector, in accordance with at leastone aspect of the present disclosure.

FIG. 90 illustrates a perspective view of an end effector of a surgicalstapling and cutting instrument including predetermined zones, inaccordance with at least one aspect of the present disclosure, inaccordance with at least one aspect of the present disclosure.

FIG. 91 illustrates a straightened partial cross-sectional of the endeffector of the curved surgical stapling and cutting instrument of FIG.88 with a tissue disposed between jaws of the end effector, inaccordance with at least one aspect of the present disclosure.

FIG. 92 illustrates a straightened partial cross-sectional of the endeffector of the curved surgical stapling and cutting instrument of FIG.88 with a tissue disposed between jaws of the end effector, inaccordance with at least one aspect of the present disclosure.

FIG. 93 illustrates a straightened partial cross-sectional of the endeffector of the curved surgical stapling and cutting instrument of FIG.88 with a tissue disposed between jaws of the end effector, inaccordance with at least one aspect of the present disclosure.

FIG. 94 illustrates the tissue of FIG. 91 being grasped by the endeffector of FIG. 88, in accordance with at least one aspect of thepresent disclosure.

FIG. 95 illustrates the tissue of FIG. 92 being grasped by the endeffector of FIG. 88, in accordance with at least one aspect of thepresent disclosure.

FIG. 96 illustrates the tissue of FIG. 93 being grasped by the endeffector of FIG. 88, in accordance with at least one aspect of thepresent disclosure.

FIG. 97 illustrates a logic flow diagram of a process depicting acontrol program or a logic configuration for identifying irregularitiesin tissue distribution within an end effector of a surgical instrument,in accordance with at least one aspect of the present disclosure.

FIG. 98 is a graph representing tissue impedance measurements at thethree predetermined of the end effector of FIG. 88 over time, inaccordance with at least one aspect of the present disclosure.

FIG. 99 is a graph representing Force-To-Close the end effector of FIG.88 around the tissue of FIG. 91 and motor speed of a motor effecting theend effector closure plotted against time, in accordance with at leastone aspect of the present disclosure.

FIG. 100 is a graph representing Force-To-Close the end effector of FIG.88 around the tissue of FIG. 92 and motor speed of a motor effecting theend effector closure plotted against time, in accordance with at leastone aspect of the present disclosure.

FIG. 101 is a graph representing Force-To-Close the end effector of FIG.88 around the tissue of FIG. 93 and motor speed of a motor effecting theend effector closure plotted against time, in accordance with at leastone aspect of the present disclosure.

FIG. 102 illustrates a control system of a surgical instrument, inaccordance with at least one aspect of the present disclosure.

FIG. 103 illustrates a diagram of a surgical instrument centered on alinear staple transection line using the benefit of centering tools andtechniques described in connection with FIGS. 104-106, in accordancewith at least one aspect of the present disclosure.

FIGS. 104-106 illustrate a process of aligning an anvil trocar of acircular stapler to a staple overlap portion of a linear staple linecreated by a double-stapling technique, in accordance with at least oneaspect of the present disclosure, where:

FIG. 104 illustrates an anvil trocar of a circular stapler that is notaligned with a staple overlap portion of a linear staple line created bya double-stapling technique;

FIG. 105 illustrates an anvil trocar of a circular stapler that isaligned with the center of the staple overlap portion of the linearstaple line created by a double-stapling technique; and

FIG. 106 illustrates a centering tool displayed on a surgical hubdisplay showing a staple overlap portion of a linear staple line createdby a double-stapling technique to be cut out by a circular stapler,where the anvil trocar is not aligned with the staple overlap portion ofthe double staple line as shown in FIG. 104.

FIGS. 107 and 108 illustrate a before image and an after image of acentering tool, in accordance with at least one aspect of the presentdisclosure, where:

FIG. 107 illustrates an image of a projected cut path of an anvil trocarand circular knife before alignment with the target alignment ringcircumscribing the image of the linear staple line over the image of thestaple overlap portion presented on a surgical hub display;

FIG. 108 illustrates an image of a projected cut path of an anvil trocarand circular knife after alignment with the target alignment ringcircumscribing the image of the linear staple line over the image of thestaple overlap portion presented on a surgical hub display.

FIGS. 109-111 illustrate a process of aligning an anvil trocar of acircular stapler to a center of a linear staple line, in accordance withat least one aspect of the present disclosure, where:

FIG. 109 illustrates the anvil trocar out of alignment with the centerof the linear staple line;

FIG. 110 illustrates the anvil trocar in alignment with the center ofthe linear staple line;

FIG. 111 illustrates a centering tool displayed on a surgical hubdisplay of a linear staple line, where the anvil trocar is not alignedwith the staple overlap portion of the double staple line as shown inFIG. 109.

FIG. 112 is an image of a standard reticle field view of a linear stapleline transection of a surgical as viewed through a laparoscope displayedon the surgical hub display, in accordance with at least one aspect ofthe present disclosure.

FIG. 113 is an image of a laser-assisted reticle field of view of thesurgical site shown in FIG. 112 before the anvil trocar and circularknife of the circular stapler are aligned to the center of the linearstaple line, in accordance with at least one aspect of the presentdisclosure.

FIG. 114 is an image of a laser-assisted reticle field of view of thesurgical site shown in FIG. 113 after the anvil trocar and circularknife of the circular stapler are aligned to the center of the linearstaple line, in accordance with at least one aspect of the presentdisclosure.

FIG. 115 illustrates a partial perspective view of a circular staplershowing a circular stapler trocar including a staple cartridge, whichhas four predetermined zones, in accordance with at least one aspect ofthe present disclosure.

FIG. 116 illustrates a partial perspective view of a circular staplershowing a circular stapler trocar including a staple cartridge, whichhas eight predetermined zones, in accordance with at least one aspect ofthe present disclosure.

FIG. 117 illustrates, on the left, two tissues including previouslydeployed staples properly disposed onto the staple cartridge of FIG.115, and on the right, two tissues including previously deployed staplesproperly disposed onto the staple cartridge of FIG. 115, in accordancewith at least one aspect of the present disclosure.

FIG. 118 illustrates, on the left, a tissue including previouslydeployed staples properly disposed onto the staple cartridge of FIG.115, and on the right, a tissue including previously deployed staplesproperly disposed onto the staple cartridge of FIG. 115, in accordancewith at least one aspect of the present disclosure.

FIG. 119 illustrates two tissues including previously deployed staplesproperly disposed onto the staple cartridge of FIG. 116, in accordancewith at least one aspect of the present disclosure.

FIG. 120 illustrates two tissues including previously deployed staplesimproperly disposed onto the staple cartridge of FIG. 116, in accordancewith at least one aspect of the present disclosure.

FIG. 121 is a graph depicting a tissue impedance signature of theproperly disposed tissues of FIG. 119, in accordance with at least oneaspect of the present disclosure.

FIG. 122 is a graph depicting a tissue impedance signature of theimproperly disposed tissues of FIG. 120, in accordance with at least oneaspect of the present disclosure.

FIG. 123 illustrates a tissue including previously deployed staplesproperly disposed onto the staple cartridge of FIG. 116, in accordancewith at least one aspect of the present disclosure.

FIG. 124 illustrates a tissue including previously deployed staplesimproperly disposed onto the staple cartridge of FIG. 116, in accordancewith at least one aspect of the present disclosure.

FIG. 125 is a graph depicting a tissue impedance signature of theproperly disposed tissue of FIG. 123, in accordance with at least oneaspect of the present disclosure.

FIG. 126 is a graph depicting a tissue impedance signature of theimproperly disposed tissue of FIG. 124, in accordance with at least oneaspect of the present disclosure.

FIG. 127 illustrates a logic flow diagram of a process 25600 depicting acontrol program or a logic configuration for properly positioning apreviously-stapled tissue within an end effector, in accordance with atleast one aspect of the present disclosure.

FIG. 128 illustrates an end effector extending from a shaft of asurgical instrument in an open configuration, in accordance with atleast one aspect of the present disclosure.

FIG. 129 illustrates the end effector of FIG. 128 with a blood vessel(BV) extending between the jaws of the end effector, in accordance withat least one aspect of the present disclosure.

FIG. 130 illustrates the end effector of FIG. 128 in a closedconfiguration without tissue, in accordance with at least one aspect ofthe present disclosure.

FIG. 131 illustrates the end effector of FIG. 128 with tissue graspedbetween the jaws of the end effector, in accordance with at least oneaspect of the present disclosure.

FIG. 132 illustrates an end effector extending from a shaft of asurgical instrument in an open configuration, in accordance with atleast one aspect of the present disclosure.

FIG. 133 illustrates the end effector of FIG. 128 in a closedconfiguration without tissue, in accordance with at least one aspect ofthe present disclosure.

FIG. 134 illustrates the end effector of FIG. 128 with tissue graspedbetween the jaws of the end effector, in accordance with at least oneaspect of the present disclosure.

DESCRIPTION

Applicant of the present application owns the following U.S. patentapplications, filed on Jun. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. ______, titled CAPACITIVE        COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY ELEMENTS, Attorney        Docket No. END8542USNP/170755;    -   U.S. patent application Ser. No. ______, titled CONTROLLING A        SURGICAL INSTRUMENT ACCORDING TO SENSED CLOSURE PARAMETERS,        Attorney Docket No. END8543USNP/170760;    -   U.S. patent application Ser. No. ______, titled SYSTEMS FOR        ADJUSTING END EFFECTOR PARAMETERS BASED ON PERIOPERATIVE        INFORMATION, Attorney Docket No. END8543USNP1/170760-1;    -   U.S. patent application Ser. No. ______, titled SAFETY SYSTEMS        FOR SMART POWERED SURGICAL STAPLING, Attorney Docket No.        END8543USNP2/170760-2;    -   U.S. patent application Ser. No. ______, titled SAFETY SYSTEMS        FOR SMART POWERED SURGICAL STAPLING, Attorney Docket No.        END8543USNP3/170760-3;    -   U.S. patent application Ser. No. ______, titled SURGICAL SYSTEMS        FOR DETECTING END EFFECTOR TISSUE DISTRIBUTION IRREGULARITIES,        Attorney Docket No. END8543USNP4/170760-4;    -   U.S. patent application Ser. No. ______, titled SYSTEMS FOR        DETECTING PROXIMITY OF SURGICAL END EFFECTOR TO CANCEROUS        TISSUE, Attorney Docket No. END8543USNP5/170760-5;    -   U.S. patent application Ser. No. ______, titled SURGICAL        INSTRUMENT CARTRIDGE SENSOR ASSEMBLIES, Attorney Docket No.        END8543USNP6/170760-6;    -   U.S. patent application Ser. No. ______, titled VARIABLE OUTPUT        CARTRIDGE SENSOR ASSEMBLY, Attorney Docket No.        END8543USNP7/170760-7;    -   U.S. patent application Ser. No. ______, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE ELECTRODE, Attorney Docket No.        END8544USNP/170761;    -   U.S. patent application Ser. No. ______, titled SURGICAL        INSTRUMENT HAVING A FLEXIBLE CIRCUIT, Attorney Docket No.        END8544USNP1/170761-1;    -   U.S. patent application Ser. No. ______, titled SURGICAL        INSTRUMENT WITH A TISSUE MARKING ASSEMBLY, Attorney Docket No.        END8544USNP2/170761-2;    -   U.S. patent application Ser. No. ______, titled SURGICAL SYSTEMS        WITH PRIORITIZED DATA TRANSMISSION CAPABILITIES, Attorney Docket        No. END8544USNP3/170761-3;    -   U.S. patent application Ser. No. ______, titled SURGICAL        EVACUATION SENSING AND MOTOR CONTROL, Attorney Docket No.        END8545USNP/170762;    -   U.S. patent application Ser. No. ______, titled SURGICAL        EVACUATION FLOW PATHS, Attorney Docket No.        END8545USNP2/170762-2;    -   U.S. patent application Ser. No. ______, titled SURGICAL        EVACUATION SENSING AND GENERATOR CONTROL, Attorney Docket No.        END8545USNP3/170762-3;    -   U.S. patent application Ser. No. ______, titled SURGICAL        EVACUATION SENSING AND DISPLAY, Attorney Docket No.        END8545USNP4/170762-4;    -   U.S. patent application Ser. No. ______, titled COMMUNICATION OF        SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR CLOUD IN SMOKE        EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM, Attorney        Docket No. END8546USNP/170763;    -   U.S. patent application Ser. No. ______, titled SMOKE EVACUATION        SYSTEM INCLUDING A SEGMENTED CONTROL CIRCUIT FOR INTERACTIVE        SURGICAL PLATFORM, Attorney Docket No. END8546USNP1/170763-1;    -   U.S. patent application Ser. No. ______, titled SURGICAL        EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR COMMUNICATION        BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE, Attorney Docket        No. END8547USNP/170764; and    -   U.S. patent application Ser. No. ______, titled DUAL IN-SERIES        LARGE AND SMALL DROPLET FILTERS, Attorney Docket No.        END8548USNP/170765.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Jun. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/691,228, titled        A METHOD OF USING REINFORCED FLEX CIRCUITS WITH MULTIPLE SENSORS        WITH ELECTROSURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/691,230, titled        SURGICAL INSTRUMENT HAVING A FLEXIBLE ELECTRODE;    -   U.S. Provisional Patent Application Ser. No. 62/691,219, titled        SURGICAL EVACUATION SENSING AND MOTOR CONTROL;    -   U.S. Provisional Patent Application Ser. No. 62/691,257, titled        COMMUNICATION OF SMOKE EVACUATION SYSTEM PARAMETERS TO HUB OR        CLOUD IN SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL        PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/691,262, titled        SURGICAL EVACUATION SYSTEM WITH A COMMUNICATION CIRCUIT FOR        COMMUNICATION BETWEEN A FILTER AND A SMOKE EVACUATION DEVICE;        and    -   U.S. Provisional Patent Application Ser. No. 62/691,251, titled        DUAL IN-SERIES LARGE AND SMALL DROPLET FILTERS.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,641, titled INTERACTIVE        SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,648, titled INTERACTIVE        SURGICAL SYSTEMS WITH CONDITION HANDLING OF DEVICES AND DATA        CAPABILITIES;    -   U.S. patent application Ser. No. 15/940,656, titled SURGICAL HUB        COORDINATION OF CONTROL AND COMMUNICATION OF OPERATING ROOM        DEVICES;    -   U.S. patent application Ser. No. 15/940,666, titled SPATIAL        AWARENESS OF SURGICAL HUBS IN OPERATING ROOMS;    -   U.S. patent application Ser. No. 15/940,670, titled COOPERATIVE        UTILIZATION OF DATA DERIVED FROM SECONDARY SOURCES BY        INTELLIGENT SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,677, titled SURGICAL HUB        CONTROL ARRANGEMENTS;    -   U.S. patent application Ser. No. 15/940,632, titled DATA        STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. patent application Ser. No. 15/940,640, titled        COMMUNICATION HUB AND STORAGE DEVICE FOR STORING PARAMETERS AND        STATUS OF A SURGICAL DEVICE TO BE SHARED WITH CLOUD BASED        ANALYTICS SYSTEMS;    -   U.S. patent application Ser. No. 15/940,645, titled SELF        DESCRIBING DATA PACKETS GENERATED AT AN ISSUING INSTRUMENT;    -   U.S. patent application Ser. No. 15/940,649, titled DATA PAIRING        TO INTERCONNECT A DEVICE MEASURED PARAMETER WITH AN OUTCOME;    -   U.S. patent application Ser. No. 15/940,654, titled SURGICAL HUB        SITUATIONAL AWARENESS;    -   U.S. patent application Ser. No. 15/940,663, titled SURGICAL        SYSTEM DISTRIBUTED PROCESSING;    -   U.S. patent application Ser. No. 15/940,668, titled AGGREGATION        AND REPORTING OF SURGICAL HUB DATA;    -   U.S. patent application Ser. No. 15/940,671, titled SURGICAL HUB        SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING THEATER;    -   U.S. patent application Ser. No. 15/940,686, titled DISPLAY OF        ALIGNMENT OF STAPLE CARTRIDGE TO PRIOR LINEAR STAPLE LINE;    -   U.S. patent application Ser. No. 15/940,700, titled STERILE        FIELD INTERACTIVE CONTROL DISPLAYS;    -   U.S. patent application Ser. No. 15/940,629, titled COMPUTER        IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. patent application Ser. No. 15/940,704, titled USE OF LASER        LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE PROPERTIES OF        BACK SCATTERED LIGHT;    -   U.S. patent application Ser. No. 15/940,722, titled        CHARACTERIZATION OF TISSUE IRREGULARITIES THROUGH THE USE OF        MONO-CHROMATIC LIGHT REFRACTIVITY; and    -   U.S. patent application Ser. No. 15/940,742, titled DUAL CMOS        ARRAY IMAGING.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,636, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. patent application Ser. No. 15/940,653, titled ADAPTIVE        CONTROL PROGRAM UPDATES FOR SURGICAL HUBS;    -   U.S. patent application Ser. No. 15/940,660, titled CLOUD-BASED        MEDICAL ANALYTICS FOR CUSTOMIZATION AND RECOMMENDATIONS TO A        USER;    -   U.S. patent application Ser. No. 15/940,679, titled CLOUD-BASED        MEDICAL ANALYTICS FOR LINKING OF LOCAL USAGE TRENDS WITH THE        RESOURCE ACQUISITION BEHAVIORS OF LARGER DATA SET;    -   U.S. patent application Ser. No. 15/940,694, titled CLOUD-BASED        MEDICAL ANALYTICS FOR MEDICAL FACILITY SEGMENTED        INDIVIDUALIZATION OF INSTRUMENT FUNCTION;    -   U.S. patent application Ser. No. 15/940,634, titled CLOUD-BASED        MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION TRENDS AND        REACTIVE MEASURES;    -   U.S. patent application Ser. No. 15/940,706, titled DATA        HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK; and    -   U.S. patent application Ser. No. 15/940,675, titled CLOUD        INTERFACE FOR COUPLED SURGICAL DEVICES.

Applicant of the present application owns the following U.S. patentapplications, filed on Mar. 29, 2018, the disclosure of each of which isherein incorporated by reference in its entirety:

-   -   U.S. patent application Ser. No. 15/940,627, titled DRIVE        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,637, titled        COMMUNICATION ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS;    -   U.S. patent application Ser. No. 15/940,642, titled CONTROLS FOR        ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,676, titled AUTOMATIC        TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,680, titled CONTROLLERS        FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,683, titled COOPERATIVE        SURGICAL ACTIONS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. patent application Ser. No. 15/940,690, titled DISPLAY        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS; and    -   U.S. patent application Ser. No. 15/940,711, titled SENSING        ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 28, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/649,302, titled        INTERACTIVE SURGICAL SYSTEMS WITH ENCRYPTED COMMUNICATION        CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/649,294, titled        DATA STRIPPING METHOD TO INTERROGATE PATIENT RECORDS AND CREATE        ANONYMIZED RECORD;    -   U.S. Provisional Patent Application Ser. No. 62/649,300, titled        SURGICAL HUB SITUATIONAL AWARENESS;    -   U.S. Provisional Patent Application Ser. No. 62/649,309, titled        SURGICAL HUB SPATIAL AWARENESS TO DETERMINE DEVICES IN OPERATING        THEATER;    -   U.S. Provisional Patent Application Ser. No. 62/649,310, titled        COMPUTER IMPLEMENTED INTERACTIVE SURGICAL SYSTEMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,291, titled        USE OF LASER LIGHT AND RED-GREEN-BLUE COLORATION TO DETERMINE        PROPERTIES OF BACK SCATTERED LIGHT;    -   U.S. Provisional Patent Application Ser. No. 62/649,296, titled        ADAPTIVE CONTROL PROGRAM UPDATES FOR SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,333, titled        CLOUD-BASED MEDICAL ANALYTICS FOR CUSTOMIZATION AND        RECOMMENDATIONS TO A USER;    -   U.S. Provisional Patent Application Ser. No. 62/649,327, titled        CLOUD-BASED MEDICAL ANALYTICS FOR SECURITY AND AUTHENTICATION        TRENDS AND REACTIVE MEASURES;    -   U.S. Provisional Patent Application Ser. No. 62/649,315, titled        DATA HANDLING AND PRIORITIZATION IN A CLOUD ANALYTICS NETWORK;    -   U.S. Provisional Patent Application Ser. No. 62/649,313, titled        CLOUD INTERFACE FOR COUPLED SURGICAL DEVICES;    -   U.S. Provisional Patent Application Ser. No. 62/649,320, titled        DRIVE ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS;    -   U.S. Provisional Patent Application Ser. No. 62/649,307, titled        AUTOMATIC TOOL ADJUSTMENTS FOR ROBOT-ASSISTED SURGICAL        PLATFORMS; and    -   U.S. Provisional Patent Application Ser. No. 62/649,323, titled        SENSING ARRANGEMENTS FOR ROBOT-ASSISTED SURGICAL PLATFORMS.

Applicant of the present application owns the following U.S. Provisionalpatent application, filed on Apr. 19, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/659,900, titled        METHOD OF HUB COMMUNICATION.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 30, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/650,887, titled        SURGICAL SYSTEMS WITH OPTIMIZED SENSING CAPABILITIES;    -   U.S. Provisional Patent Application Ser. No. 62/650,877, titled        SURGICAL SMOKE EVACUATION SENSING AND CONTROLS;    -   U.S. Provisional Patent Application Ser. No. 62/650,882, titled        SMOKE EVACUATION MODULE FOR INTERACTIVE SURGICAL PLATFORM; and    -   U.S. Provisional Patent Application Ser. No. 62/650,898, titled        CAPACITIVE COUPLED RETURN PATH PAD WITH SEPARABLE ARRAY        ELEMENTS.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Mar. 8, 2018, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/640,417, titled        TEMPERATURE CONTROL IN ULTRASONIC DEVICE AND CONTROL SYSTEM        THEREFOR; and    -   U.S. Provisional Patent Application Ser. No. 62/640,415, titled        ESTIMATING STATE OF ULTRASONIC END EFFECTOR AND CONTROL SYSTEM        THEREFOR.

Applicant of the present application owns the following U.S. Provisionalpatent applications, filed on Dec. 28, 2017, the disclosure of each ofwhich is herein incorporated by reference in its entirety:

-   -   U.S. Provisional Patent Application Ser. No. 62/611,341, titled        INTERACTIVE SURGICAL PLATFORM;    -   U.S. Provisional Patent Application Ser. No. 62/611,340, titled        CLOUD-BASED MEDICAL ANALYTICS; and    -   U.S. Provisional Patent Application Ser. No. 62/611,339, titled        ROBOT ASSISTED SURGICAL PLATFORM.

Before explaining various aspects of surgical devices and generators indetail, it should be noted that the illustrative examples are notlimited in application or use to the details of construction andarrangement of parts illustrated in the accompanying drawings anddescription. The illustrative examples may be implemented orincorporated in other aspects, variations and modifications, and may bepracticed or carried out in various ways. Further, unless otherwiseindicated, the terms and expressions employed herein have been chosenfor the purpose of describing the illustrative examples for theconvenience of the reader and are not for the purpose of limitationthereof. Also, it will be appreciated that one or more of thefollowing-described aspects, expressions of aspects, and/or examples,can be combined with any one or more of the other following-describedaspects, expressions of aspects and/or examples.

Referring to FIG. 1, a computer-implemented interactive surgical system100 includes one or more surgical systems 102 and a cloud-based system(e.g., the cloud 104 that may include a remote server 113 coupled to astorage device 105). Each surgical system 102 includes at least onesurgical hub 106 in communication with the cloud 104 that may include aremote server 113. In one example, as illustrated in FIG. 1, thesurgical system 102 includes a visualization system 108, a roboticsystem 110, and a handheld intelligent surgical instrument 112, whichare configured to communicate with one another and/or the hub 106. Insome aspects, a surgical system 102 may include an M number of hubs 106,an N number of visualization systems 108, an O number of robotic systems110, and a P number of handheld intelligent surgical instruments 112,where M, N, O, and P are integers greater than or equal to one.

FIG. 3 depicts an example of a surgical system 102 being used to performa surgical procedure on a patient who is lying down on an operatingtable 114 in a surgical operating room 116. A robotic system 110 is usedin the surgical procedure as a part of the surgical system 102. Therobotic system 110 includes a surgeon's console 118, a patient side cart120 (surgical robot), and a surgical robotic hub 122. The patient sidecart 120 can manipulate at least one removably coupled surgical tool 117through a minimally invasive incision in the body of the patient whilethe surgeon views the surgical site through the surgeon's console 118.An image of the surgical site can be obtained by a medical imagingdevice 124, which can be manipulated by the patient side cart 120 toorient the imaging device 124. The robotic hub 122 can be used toprocess the images of the surgical site for subsequent display to thesurgeon through the surgeon's console 118.

Other types of robotic systems can be readily adapted for use with thesurgical system 102. Various examples of robotic systems and surgicaltools that are suitable for use with the present disclosure aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,339,titled ROBOT ASSISTED SURGICAL PLATFORM, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

Various examples of cloud-based analytics that are performed by thecloud 104, and are suitable for use with the present disclosure, aredescribed in U.S. Provisional Patent Application Ser. No. 62/611,340,titled CLOUD-BASED MEDICAL ANALYTICS, filed Dec. 28, 2017, thedisclosure of which is herein incorporated by reference in its entirety.

In various aspects, the imaging device 124 includes at least one imagesensor and one or more optical components. Suitable image sensorsinclude, but are not limited to, Charge-Coupled Device (CCD) sensors andComplementary Metal-Oxide Semiconductor (CMOS) sensors.

The optical components of the imaging device 124 may include one or moreillumination sources and/or one or more lenses. The one or moreillumination sources may be directed to illuminate portions of thesurgical field. The one or more image sensors may receive lightreflected or refracted from the surgical field, including lightreflected or refracted from tissue and/or surgical instruments.

The one or more illumination sources may be configured to radiateelectromagnetic energy in the visible spectrum as well as the invisiblespectrum. The visible spectrum, sometimes referred to as the opticalspectrum or luminous spectrum, is that portion of the electromagneticspectrum that is visible to (i.e., can be detected by) the human eye andmay be referred to as visible light or simply light. A typical human eyewill respond to wavelengths in air that are from about 380 nm to about750 nm.

The invisible spectrum (i.e., the non-luminous spectrum) is that portionof the electromagnetic spectrum that lies below and above the visiblespectrum (i.e., wavelengths below about 380 nm and above about 750 nm).The invisible spectrum is not detectable by the human eye. Wavelengthsgreater than about 750 nm are longer than the red visible spectrum, andthey become invisible infrared (IR), microwave, and radioelectromagnetic radiation. Wavelengths less than about 380 nm areshorter than the violet spectrum, and they become invisible ultraviolet,x-ray, and gamma ray electromagnetic radiation.

In various aspects, the imaging device 124 is configured for use in aminimally invasive procedure. Examples of imaging devices suitable foruse with the present disclosure include, but not limited to, anarthroscope, angioscope, bronchoscope, choledochoscope, colonoscope,cytoscope, duodenoscope, enteroscope, esophagogastro-duodenoscope(gastroscope), endoscope, laryngoscope, nasopharyngo-neproscope,sigmoidoscope, thoracoscope, and ureteroscope.

In one aspect, the imaging device employs multi-spectrum monitoring todiscriminate topography and underlying structures. A multi-spectralimage is one that captures image data within specific wavelength rangesacross the electromagnetic spectrum. The wavelengths may be separated byfilters or by the use of instruments that are sensitive to particularwavelengths, including light from frequencies beyond the visible lightrange, e.g., IR and ultraviolet. Spectral imaging can allow extractionof additional information the human eye fails to capture with itsreceptors for red, green, and blue. The use of multi-spectral imaging isdescribed in greater detail under the heading “Advanced ImagingAcquisition Module” in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety. Multi-spectrum monitoring can be a useful tool in relocating asurgical field after a surgical task is completed to perform one or moreof the previously described tests on the treated tissue.

It is axiomatic that strict sterilization of the operating room andsurgical equipment is required during any surgery. The strict hygieneand sterilization conditions required in a “surgical theater,” i.e., anoperating or treatment room, necessitate the highest possible sterilityof all medical devices and equipment. Part of that sterilization processis the need to sterilize anything that comes in contact with the patientor penetrates the sterile field, including the imaging device 124 andits attachments and components. It will be appreciated that the sterilefield may be considered a specified area, such as within a tray or on asterile towel, that is considered free of microorganisms, or the sterilefield may be considered an area, immediately around a patient, who hasbeen prepared for a surgical procedure. The sterile field may includethe scrubbed team members, who are properly attired, and all furnitureand fixtures in the area.

In various aspects, the visualization system 108 includes one or moreimaging sensors, one or more image-processing units, one or more storagearrays, and one or more displays that are strategically arranged withrespect to the sterile field, as illustrated in FIG. 2. In one aspect,the visualization system 108 includes an interface for HL7, PACS, andEMR. Various components of the visualization system 108 are describedunder the heading “Advanced Imaging Acquisition Module” in U.S.Provisional Patent Application Ser. No. 62/611,341, titled INTERACTIVESURGICAL PLATFORM, filed Dec. 28, 2017, the disclosure of which isherein incorporated by reference in its entirety.

As illustrated in FIG. 2, a primary display 119 is positioned in thesterile field to be visible to an operator at the operating table 114.In addition, a visualization tower 111 is positioned outside the sterilefield. The visualization tower 111 includes a first non-sterile display107 and a second non-sterile display 109, which face away from eachother. The visualization system 108, guided by the hub 106, isconfigured to utilize the displays 107, 109, and 119 to coordinateinformation flow to operators inside and outside the sterile field. Forexample, the hub 106 may cause the visualization system 108 to display asnapshot of a surgical site, as recorded by an imaging device 124, on anon-sterile display 107 or 109, while maintaining a live feed of thesurgical site on the primary display 119. The snapshot on thenon-sterile display 107 or 109 can permit a non-sterile operator toperform a diagnostic step relevant to the surgical procedure, forexample.

In one aspect, the hub 106 is also configured to route a diagnosticinput or feedback entered by a non-sterile operator at the visualizationtower 111 to the primary display 119 within the sterile field, where itcan be viewed by a sterile operator at the operating table. In oneexample, the input can be in the form of a modification to the snapshotdisplayed on the non-sterile display 107 or 109, which can be routed tothe primary display 119 by the hub 106.

Referring to FIG. 2, a surgical instrument 112 is being used in thesurgical procedure as part of the surgical system 102. The hub 106 isalso configured to coordinate information flow to a display of thesurgical instrument 112. For example, in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, the disclosure of which is herein incorporated byreference in its entirety. A diagnostic input or feedback entered by anon-sterile operator at the visualization tower 111 can be routed by thehub 106 to the surgical instrument display 115 within the sterile field,where it can be viewed by the operator of the surgical instrument 112.Example surgical instruments that are suitable for use with the surgicalsystem 102 are described under the heading “Surgical InstrumentHardware” and in U.S. Provisional Patent Application Ser. No.62/611,341, titled INTERACTIVE SURGICAL PLATFORM, filed Dec. 28, 2017,the disclosure of which is herein incorporated by reference in itsentirety, for example.

Referring now to FIG. 3, a hub 106 is depicted in communication with avisualization system 108, a robotic system 110, and a handheldintelligent surgical instrument 112. The hub 106 includes a hub display135, an imaging module 138, a generator module 140, a communicationmodule 130, a processor module 132, and a storage array 134. In certainaspects, as illustrated in FIG. 3, the hub 106 further includes a smokeevacuation module 126 and/or a suction/irrigation module 128.

During a surgical procedure, energy application to tissue, for sealingand/or cutting, is generally associated with smoke evacuation, suctionof excess fluid, and/or irrigation of the tissue. Fluid, power, and/ordata lines from different sources are often entangled during thesurgical procedure. Valuable time can be lost addressing this issueduring a surgical procedure. Detangling the lines may necessitatedisconnecting the lines from their respective modules, which may requireresetting the modules. The hub modular enclosure 136 offers a unifiedenvironment for managing the power, data, and fluid lines, which reducesthe frequency of entanglement between such lines.

Aspects of the present disclosure present a surgical hub for use in asurgical procedure that involves energy application to tissue at asurgical site. The surgical hub includes a hub enclosure and a combogenerator module slidably receivable in a docking station of the hubenclosure. The docking station includes data and power contacts. Thecombo generator module includes two or more of an ultrasonic energygenerator component, a bipolar RF energy generator component, and amonopolar RF energy generator component that are housed in a singleunit. In one aspect, the combo generator module also includes a smokeevacuation component, at least one energy delivery cable for connectingthe combo generator module to a surgical instrument, at least one smokeevacuation component configured to evacuate smoke, fluid, and/orparticulates generated by the application of therapeutic energy to thetissue, and a fluid line extending from the remote surgical site to thesmoke evacuation component.

In one aspect, the fluid line is a first fluid line and a second fluidline extends from the remote surgical site to a suction and irrigationmodule slidably received in the hub enclosure. In one aspect, the hubenclosure comprises a fluid interface.

Certain surgical procedures may require the application of more than oneenergy type to the tissue. One energy type may be more beneficial forcutting the tissue, while another different energy type may be morebeneficial for sealing the tissue. For example, a bipolar generator canbe used to seal the tissue while an ultrasonic generator can be used tocut the sealed tissue. Aspects of the present disclosure present asolution where a hub modular enclosure 136 is configured to accommodatedifferent generators, and facilitate an interactive communicationtherebetween. One of the advantages of the hub modular enclosure 136 isenabling the quick removal and/or replacement of various modules.

Aspects of the present disclosure present a modular surgical enclosurefor use in a surgical procedure that involves energy application totissue. The modular surgical enclosure includes a first energy-generatormodule, configured to generate a first energy for application to thetissue, and a first docking station comprising a first docking port thatincludes first data and power contacts, wherein the firstenergy-generator module is slidably movable into an electricalengagement with the power and data contacts and wherein the firstenergy-generator module is slidably movable out of the electricalengagement with the first power and data contacts.

Further to the above, the modular surgical enclosure also includes asecond energy-generator module configured to generate a second energy,different than the first energy, for application to the tissue, and asecond docking station comprising a second docking port that includessecond data and power contacts, wherein the second energy-generatormodule is slidably movable into an electrical engagement with the powerand data contacts, and wherein the second energy-generator module isslidably movable out of the electrical engagement with the second powerand data contacts.

In addition, the modular surgical enclosure also includes acommunication bus between the first docking port and the second dockingport, configured to facilitate communication between the firstenergy-generator module and the second energy-generator module.

Referring to FIGS. 3-7, aspects of the present disclosure are presentedfor a hub modular enclosure 136 that allows the modular integration of agenerator module 140, a smoke evacuation module 126, and asuction/irrigation module 128. The hub modular enclosure 136 furtherfacilitates interactive communication between the modules 140, 126, 128.As illustrated in FIG. 5, the generator module 140 can be a generatormodule with integrated monopolar, bipolar, and ultrasonic componentssupported in a single housing unit 139 slidably insertable into the hubmodular enclosure 136. As illustrated in FIG. 5, the generator module140 can be configured to connect to a monopolar device 146, a bipolardevice 147, and an ultrasonic device 148. Alternatively, the generatormodule 140 may comprise a series of monopolar, bipolar, and/orultrasonic generator modules that interact through the hub modularenclosure 136. The hub modular enclosure 136 can be configured tofacilitate the insertion of multiple generators and interactivecommunication between the generators docked into the hub modularenclosure 136 so that the generators would act as a single generator.

In one aspect, the hub modular enclosure 136 comprises a modular powerand communication backplane 149 with external and wireless communicationheaders to enable the removable attachment of the modules 140, 126, 128and interactive communication therebetween.

In one aspect, the hub modular enclosure 136 includes docking stations,or drawers, 151, herein also referred to as drawers, which areconfigured to slidably receive the modules 140, 126, 128. FIG. 4illustrates a partial perspective view of a surgical hub enclosure 136,and a combo generator module 145 slidably receivable in a dockingstation 151 of the surgical hub enclosure 136. A docking port 152 withpower and data contacts on a rear side of the combo generator module 145is configured to engage a corresponding docking port 150 with power anddata contacts of a corresponding docking station 151 of the hub modularenclosure 136 as the combo generator module 145 is slid into positionwithin the corresponding docking station 151 of the hub module enclosure136. In one aspect, the combo generator module 145 includes a bipolar,ultrasonic, and monopolar module and a smoke evacuation moduleintegrated together into a single housing unit 139, as illustrated inFIG. 5.

In various aspects, the smoke evacuation module 126 includes a fluidline 154 that conveys captured/collected smoke and/or fluid away from asurgical site and to, for example, the smoke evacuation module 126.Vacuum suction originating from the smoke evacuation module 126 can drawthe smoke into an opening of a utility conduit at the surgical site. Theutility conduit, coupled to the fluid line, can be in the form of aflexible tube terminating at the smoke evacuation module 126. Theutility conduit and the fluid line define a fluid path extending towardthe smoke evacuation module 126 that is received in the hub enclosure136.

In various aspects, the suction/irrigation module 128 is coupled to asurgical tool comprising an aspiration fluid line and a suction fluidline. In one example, the aspiration and suction fluid lines are in theform of flexible tubes extending from the surgical site toward thesuction/irrigation module 128. One or more drive systems can beconfigured to cause irrigation and aspiration of fluids to and from thesurgical site.

In one aspect, the surgical tool includes a shaft having an end effectorat a distal end thereof and at least one energy treatment associatedwith the end effector, an aspiration tube, and an irrigation tube. Theaspiration tube can have an inlet port at a distal end thereof and theaspiration tube extends through the shaft. Similarly, an irrigation tubecan extend through the shaft and can have an inlet port in proximity tothe energy deliver implement. The energy deliver implement is configuredto deliver ultrasonic and/or RF energy to the surgical site and iscoupled to the generator module 140 by a cable extending initiallythrough the shaft.

The irrigation tube can be in fluid communication with a fluid source,and the aspiration tube can be in fluid communication with a vacuumsource. The fluid source and/or the vacuum source can be housed in thesuction/irrigation module 128. In one example, the fluid source and/orthe vacuum source can be housed in the hub enclosure 136 separately fromthe suction/irrigation module 128. In such example, a fluid interfacecan be configured to connect the suction/irrigation module 128 to thefluid source and/or the vacuum source.

In one aspect, the modules 140, 126, 128 and/or their correspondingdocking stations on the hub modular enclosure 136 may include alignmentfeatures that are configured to align the docking ports of the modulesinto engagement with their counterparts in the docking stations of thehub modular enclosure 136. For example, as illustrated in FIG. 4, thecombo generator module 145 includes side brackets 155 that areconfigured to slidably engage with corresponding brackets 156 of thecorresponding docking station 151 of the hub modular enclosure 136. Thebrackets cooperate to guide the docking port contacts of the combogenerator module 145 into an electrical engagement with the docking portcontacts of the hub modular enclosure 136.

In some aspects, the drawers 151 of the hub modular enclosure 136 arethe same, or substantially the same size, and the modules are adjustedin size to be received in the drawers 151. For example, the sidebrackets 155 and/or 156 can be larger or smaller depending on the sizeof the module. In other aspects, the drawers 151 are different in sizeand are each designed to accommodate a particular module.

Furthermore, the contacts of a particular module can be keyed forengagement with the contacts of a particular drawer to avoid inserting amodule into a drawer with mismatching contacts.

As illustrated in FIG. 4, the docking port 150 of one drawer 151 can becoupled to the docking port 150 of another drawer 151 through acommunications link 157 to facilitate an interactive communicationbetween the modules housed in the hub modular enclosure 136. The dockingports 150 of the hub modular enclosure 136 may alternatively, oradditionally, facilitate a wireless interactive communication betweenthe modules housed in the hub modular enclosure 136. Any suitablewireless communication can be employed, such as for example AirTitan-Bluetooth.

FIG. 6 illustrates individual power bus attachments for a plurality oflateral docking ports of a lateral modular housing 160 configured toreceive a plurality of modules of a surgical hub 206. The lateralmodular housing 160 is configured to laterally receive and interconnectthe modules 161. The modules 161 are slidably inserted into dockingstations 162 of lateral modular housing 160, which includes a backplanefor interconnecting the modules 161. As illustrated in FIG. 6, themodules 161 are arranged laterally in the lateral modular housing 160.Alternatively, the modules 161 may be arranged vertically in a lateralmodular housing.

FIG. 7 illustrates a vertical modular housing 164 configured to receivea plurality of modules 165 of the surgical hub 106. The modules 165 areslidably inserted into docking stations, or drawers, 167 of verticalmodular housing 164, which includes a backplane for interconnecting themodules 165. Although the drawers 167 of the vertical modular housing164 are arranged vertically, in certain instances, a vertical modularhousing 164 may include drawers that are arranged laterally.Furthermore, the modules 165 may interact with one another through thedocking ports of the vertical modular housing 164. In the example ofFIG. 7, a display 177 is provided for displaying data relevant to theoperation of the modules 165. In addition, the vertical modular housing164 includes a master module 178 housing a plurality of sub-modules thatare slidably received in the master module 178.

In various aspects, the imaging module 138 comprises an integrated videoprocessor and a modular light source and is adapted for use with variousimaging devices. In one aspect, the imaging device is comprised of amodular housing that can be assembled with a light source module and acamera module. The housing can be a disposable housing. In at least oneexample, the disposable housing is removably coupled to a reusablecontroller, a light source module, and a camera module. The light sourcemodule and/or the camera module can be selectively chosen depending onthe type of surgical procedure. In one aspect, the camera modulecomprises a CCD sensor. In another aspect, the camera module comprises aCMOS sensor. In another aspect, the camera module is configured forscanned beam imaging. Likewise, the light source module can beconfigured to deliver a white light or a different light, depending onthe surgical procedure.

During a surgical procedure, removing a surgical device from thesurgical field and replacing it with another surgical device thatincludes a different camera or a different light source can beinefficient. Temporarily losing sight of the surgical field may lead toundesirable consequences. The module imaging device of the presentdisclosure is configured to permit the replacement of a light sourcemodule or a camera module midstream during a surgical procedure, withouthaving to remove the imaging device from the surgical field.

In one aspect, the imaging device comprises a tubular housing thatincludes a plurality of channels. A first channel is configured toslidably receive the camera module, which can be configured for asnap-fit engagement with the first channel. A second channel isconfigured to slidably receive the light source module, which can beconfigured for a snap-fit engagement with the second channel. In anotherexample, the camera module and/or the light source module can be rotatedinto a final position within their respective channels. A threadedengagement can be employed in lieu of the snap-fit engagement.

In various examples, multiple imaging devices are placed at differentpositions in the surgical field to provide multiple views. The imagingmodule 138 can be configured to switch between the imaging devices toprovide an optimal view. In various aspects, the imaging module 138 canbe configured to integrate the images from the different imaging device.

Various image processors and imaging devices suitable for use with thepresent disclosure are described in U.S. Pat. No. 7,995,045, titledCOMBINED SBI AND CONVENTIONAL IMAGE PROCESSOR, which issued on Aug. 9,2011, which is herein incorporated by reference in its entirety. Inaddition, U.S. Pat. No. 7,982,776, titled SBI MOTION ARTIFACT REMOVALAPPARATUS AND METHOD, which issued on Jul. 19, 2011, which is hereinincorporated by reference in its entirety, describes various systems forremoving motion artifacts from image data. Such systems can beintegrated with the imaging module 138. Furthermore, U.S. PatentApplication Publication No. 2011/0306840, titled CONTROLLABLE MAGNETICSOURCE TO FIXTURE INTRACORPOREAL APPARATUS, which published on Dec. 15,2011, and U.S. Patent Application Publication No. 2014/0243597, titledSYSTEM FOR PERFORMING A MINIMALLY INVASIVE SURGICAL PROCEDURE, whichpublished on Aug. 28, 2014, the disclosure of each of which is hereinincorporated by reference in its entirety.

FIG. 8 illustrates a surgical data network 201 comprising a modularcommunication hub 203 configured to connect modular devices located inone or more operating theaters of a healthcare facility, or any room ina healthcare facility specially equipped for surgical operations, to acloud-based system (e.g., the cloud 204 that may include a remote server213 coupled to a storage device 205). In one aspect, the modularcommunication hub 203 comprises a network hub 207 and/or a networkswitch 209 in communication with a network router. The modularcommunication hub 203 also can be coupled to a local computer system 210to provide local computer processing and data manipulation. The surgicaldata network 201 may be configured as passive, intelligent, orswitching. A passive surgical data network serves as a conduit for thedata, enabling it to go from one device (or segment) to another and tothe cloud computing resources. An intelligent surgical data networkincludes additional features to enable the traffic passing through thesurgical data network to be monitored and to configure each port in thenetwork hub 207 or network switch 209. An intelligent surgical datanetwork may be referred to as a manageable hub or switch. A switchinghub reads the destination address of each packet and then forwards thepacket to the correct port.

Modular devices 1 a-1 n located in the operating theater may be coupledto the modular communication hub 203. The network hub 207 and/or thenetwork switch 209 may be coupled to a network router 211 to connect thedevices 1 a-1 n to the cloud 204 or the local computer system 210. Dataassociated with the devices 1 a-1 n may be transferred to cloud-basedcomputers via the router for remote data processing and manipulation.Data associated with the devices 1 a-1 n may also be transferred to thelocal computer system 210 for local data processing and manipulation.Modular devices 2 a-2 m located in the same operating theater also maybe coupled to a network switch 209. The network switch 209 may becoupled to the network hub 207 and/or the network router 211 to connectto the devices 2 a-2 m to the cloud 204. Data associated with thedevices 2 a-2 n may be transferred to the cloud 204 via the networkrouter 211 for data processing and manipulation. Data associated withthe devices 2 a-2 m may also be transferred to the local computer system210 for local data processing and manipulation.

It will be appreciated that the surgical data network 201 may beexpanded by interconnecting multiple network hubs 207 and/or multiplenetwork switches 209 with multiple network routers 211. The modularcommunication hub 203 may be contained in a modular control towerconfigured to receive multiple devices 1 a-1 n/2 a-2 m. The localcomputer system 210 also may be contained in a modular control tower.The modular communication hub 203 is connected to a display 212 todisplay images obtained by some of the devices 1 a-1 n/2 a-2 m, forexample during surgical procedures. In various aspects, the devices 1a-1 n/2 a-2 m may include, for example, various modules such as animaging module 138 coupled to an endoscope, a generator module 140coupled to an energy-based surgical device, a smoke evacuation module126, a suction/irrigation module 128, a communication module 130, aprocessor module 132, a storage array 134, a surgical device coupled toa display, and/or a non-contact sensor module, among other modulardevices that may be connected to the modular communication hub 203 ofthe surgical data network 201.

In one aspect, the surgical data network 201 may comprise a combinationof network hub(s), network switch(es), and network router(s) connectingthe devices 1 a-1 n/2 a-2 m to the cloud. Any one of or all of thedevices 1 a-1 n/2 a-2 m coupled to the network hub or network switch maycollect data in real time and transfer the data to cloud computers fordata processing and manipulation. It will be appreciated that cloudcomputing relies on sharing computing resources rather than having localservers or personal devices to handle software applications. The word“cloud” may be used as a metaphor for “the Internet,” although the termis not limited as such. Accordingly, the term “cloud computing” may beused herein to refer to “a type of Internet-based computing,” wheredifferent services—such as servers, storage, and applications—aredelivered to the modular communication hub 203 and/or computer system210 located in the surgical theater (e.g., a fixed, mobile, temporary,or field operating room or space) and to devices connected to themodular communication hub 203 and/or computer system 210 through theInternet. The cloud infrastructure may be maintained by a cloud serviceprovider. In this context, the cloud service provider may be the entitythat coordinates the usage and control of the devices 1 a-1 n/2 a-2 mlocated in one or more operating theaters. The cloud computing servicescan perform a large number of calculations based on the data gathered bysmart surgical instruments, robots, and other computerized deviceslocated in the operating theater. The hub hardware enables multipledevices or connections to be connected to a computer that communicateswith the cloud computing resources and storage.

Applying cloud computer data processing techniques on the data collectedby the devices 1 a-1 n/2 a-2 m, the surgical data network providesimproved surgical outcomes, reduced costs, and improved patientsatisfaction. At least some of the devices 1 a-1 n/2 a-2 m may beemployed to view tissue states to assess leaks or perfusion of sealedtissue after a tissue sealing and cutting procedure. At least some ofthe devices 1 a-1 n/2 a-2 m may be employed to identify pathology, suchas the effects of diseases, using the cloud-based computing to examinedata including images of samples of body tissue for diagnostic purposes.This includes localization and margin confirmation of tissue andphenotypes. At least some of the devices 1 a-1 n/2 a-2 m may be employedto identify anatomical structures of the body using a variety of sensorsintegrated with imaging devices and techniques such as overlaying imagescaptured by multiple imaging devices. The data gathered by the devices 1a-1 n/2 a-2 m, including image data, may be transferred to the cloud 204or the local computer system 210 or both for data processing andmanipulation including image processing and manipulation. The data maybe analyzed to improve surgical procedure outcomes by determining iffurther treatment, such as the application of endoscopic intervention,emerging technologies, a targeted radiation, targeted intervention, andprecise robotics to tissue-specific sites and conditions, may bepursued. Such data analysis may further employ outcome analyticsprocessing, and using standardized approaches may provide beneficialfeedback to either confirm surgical treatments and the behavior of thesurgeon or suggest modifications to surgical treatments and the behaviorof the surgeon.

In one implementation, the operating theater devices 1 a-1 n may beconnected to the modular communication hub 203 over a wired channel or awireless channel depending on the configuration of the devices 1 a-1 nto a network hub. The network hub 207 may be implemented, in one aspect,as a local network broadcast device that works on the physical layer ofthe Open System Interconnection (OSI) model. The network hub providesconnectivity to the devices 1 a-1 n located in the same operatingtheater network. The network hub 207 collects data in the form ofpackets and sends them to the router in half duplex mode. The networkhub 207 does not store any media access control/Internet Protocol(MAC/IP) to transfer the device data. Only one of the devices 1 a-1 ncan send data at a time through the network hub 207. The network hub 207has no routing tables or intelligence regarding where to sendinformation and broadcasts all network data across each connection andto a remote server 213 (FIG. 9) over the cloud 204. The network hub 207can detect basic network errors such as collisions, but having allinformation broadcast to multiple ports can be a security risk and causebottlenecks.

In another implementation, the operating theater devices 2 a-2 m may beconnected to a network switch 209 over a wired channel or a wirelesschannel. The network switch 209 works in the data link layer of the OSImodel. The network switch 209 is a multicast device for connecting thedevices 2 a-2 m located in the same operating theater to the network.The network switch 209 sends data in the form of frames to the networkrouter 211 and works in full duplex mode. Multiple devices 2 a-2 m cansend data at the same time through the network switch 209. The networkswitch 209 stores and uses MAC addresses of the devices 2 a-2 m totransfer data.

The network hub 207 and/or the network switch 209 are coupled to thenetwork router 211 for connection to the cloud 204. The network router211 works in the network layer of the OSI model. The network router 211creates a route for transmitting data packets received from the networkhub 207 and/or network switch 211 to cloud-based computer resources forfurther processing and manipulation of the data collected by any one ofor all the devices 1 a-1 n/2 a-2 m. The network router 211 may beemployed to connect two or more different networks located in differentlocations, such as, for example, different operating theaters of thesame healthcare facility or different networks located in differentoperating theaters of different healthcare facilities. The networkrouter 211 sends data in the form of packets to the cloud 204 and worksin full duplex mode. Multiple devices can send data at the same time.The network router 211 uses IP addresses to transfer data.

In one example, the network hub 207 may be implemented as a USB hub,which allows multiple USB devices to be connected to a host computer.The USB hub may expand a single USB port into several tiers so thatthere are more ports available to connect devices to the host systemcomputer. The network hub 207 may include wired or wireless capabilitiesto receive information over a wired channel or a wireless channel. Inone aspect, a wireless USB short-range, high-bandwidth wireless radiocommunication protocol may be employed for communication between thedevices 1 a-1 n and devices 2 a-2 m located in the operating theater.

In other examples, the operating theater devices 1 a-1 n/2 a-2 m maycommunicate to the modular communication hub 203 via Bluetooth wirelesstechnology standard for exchanging data over short distances (usingshort-wavelength UHF radio waves in the ISM band from 2.4 to 2.485 GHz)from fixed and mobile devices and building personal area networks(PANs). In other aspects, the operating theater devices 1 a-1 n/2 a-2 mmay communicate to the modular communication hub 203 via a number ofwireless or wired communication standards or protocols, including butnot limited to Wi-Fi (IEEE 802.11 family), WMAX (IEEE 802.16 family),IEEE 802.20, long-term evolution (LTE), and Ev-DO, HSPA+, HSDPA+,HSUPA+, EDGE, GSM, GPRS, CDMA, TDMA, DECT, and Ethernet derivativesthereof, as well as any other wireless and wired protocols that aredesignated as 3G, 4G, 5G, and beyond. The computing module may include aplurality of communication modules. For instance, a first communicationmodule may be dedicated to shorter-range wireless communications such asWi-Fi and Bluetooth, and a second communication module may be dedicatedto longer-range wireless communications such as GPS, EDGE, GPRS, CDMA,WiMAX, LTE, Ev-DO, and others.

The modular communication hub 203 may serve as a central connection forone or all of the operating theater devices 1 a-1 n/2 a-2 m and handlesa data type known as frames. Frames carry the data generated by thedevices 1 a-1 n/2 a-2 m. When a frame is received by the modularcommunication hub 203, it is amplified and transmitted to the networkrouter 211, which transfers the data to the cloud computing resources byusing a number of wireless or wired communication standards orprotocols, as described herein.

The modular communication hub 203 can be used as a standalone device orbe connected to compatible network hubs and network switches to form alarger network. The modular communication hub 203 is generally easy toinstall, configure, and maintain, making it a good option for networkingthe operating theater devices 1 a-1 n/2 a-2 m.

FIG. 9 illustrates a computer-implemented interactive surgical system200. The computer-implemented interactive surgical system 200 is similarin many respects to the computer-implemented interactive surgical system100. For example, the computer-implemented interactive surgical system200 includes one or more surgical systems 202, which are similar in manyrespects to the surgical systems 102. Each surgical system 202 includesat least one surgical hub 206 in communication with a cloud 204 that mayinclude a remote server 213. In one aspect, the computer-implementedinteractive surgical system 200 comprises a modular control tower 236connected to multiple operating theater devices such as, for example,intelligent surgical instruments, robots, and other computerized deviceslocated in the operating theater. As shown in FIG. 10, the modularcontrol tower 236 comprises a modular communication hub 203 coupled to acomputer system 210. As illustrated in the example of FIG. 9, themodular control tower 236 is coupled to an imaging module 238 that iscoupled to an endoscope 239, a generator module 240 that is coupled toan energy device 241, a smoke evacuator module 226, a suction/irrigationmodule 228, a communication module 230, a processor module 232, astorage array 234, a smart device/instrument 235 optionally coupled to adisplay 237, and a non-contact sensor module 242. The operating theaterdevices are coupled to cloud computing resources and data storage viathe modular control tower 236. A robot hub 222 also may be connected tothe modular control tower 236 and to the cloud computing resources. Thedevices/instruments 235, visualization systems 208, among others, may becoupled to the modular control tower 236 via wired or wirelesscommunication standards or protocols, as described herein. The modularcontrol tower 236 may be coupled to a hub display 215 (e.g., monitor,screen) to display and overlay images received from the imaging module,device/instrument display, and/or other visualization systems 208. Thehub display also may display data received from devices connected to themodular control tower in conjunction with images and overlaid images.

FIG. 10 illustrates a surgical hub 206 comprising a plurality of modulescoupled to the modular control tower 236. The modular control tower 236comprises a modular communication hub 203, e.g., a network connectivitydevice, and a computer system 210 to provide local processing,visualization, and imaging, for example. As shown in FIG. 10, themodular communication hub 203 may be connected in a tiered configurationto expand the number of modules (e.g., devices) that may be connected tothe modular communication hub 203 and transfer data associated with themodules to the computer system 210, cloud computing resources, or both.As shown in FIG. 10, each of the network hubs/switches in the modularcommunication hub 203 includes three downstream ports and one upstreamport. The upstream network hub/switch is connected to a processor toprovide a communication connection to the cloud computing resources anda local display 217. Communication to the cloud 204 may be made eitherthrough a wired or a wireless communication channel.

The surgical hub 206 employs a non-contact sensor module 242 to measurethe dimensions of the operating theater and generate a map of thesurgical theater using either ultrasonic or laser-type non-contactmeasurement devices. An ultrasound-based non-contact sensor module scansthe operating theater by transmitting a burst of ultrasound andreceiving the echo when it bounces off the perimeter walls of anoperating theater as described under the heading “Surgical Hub SpatialAwareness Within an Operating Room” in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is herein incorporated by reference in itsentirety, in which the sensor module is configured to determine the sizeof the operating theater and to adjust Bluetooth-pairing distancelimits. A laser-based non-contact sensor module scans the operatingtheater by transmitting laser light pulses, receiving laser light pulsesthat bounce off the perimeter walls of the operating theater, andcomparing the phase of the transmitted pulse to the received pulse todetermine the size of the operating theater and to adjust Bluetoothpairing distance limits, for example.

The computer system 210 comprises a processor 244 and a networkinterface 245. The processor 244 is coupled to a communication module247, storage 248, memory 249, non-volatile memory 250, and input/outputinterface 251 via a system bus. The system bus can be any of severaltypes of bus structure(s) including the memory bus or memory controller,a peripheral bus or external bus, and/or a local bus using any varietyof available bus architectures including, but not limited to, 9-bit bus,Industrial Standard Architecture (ISA), Micro-Charmel Architecture(MSA), Extended ISA (EISA), Intelligent Drive Electronics (IDE), VESALocal Bus (VLB), Peripheral Component Interconnect (PCI), USB, AdvancedGraphics Port (AGP), Personal Computer Memory Card InternationalAssociation bus (PCMCIA), Small Computer Systems Interface (SCSI), orany other proprietary bus.

The processor 244 may be any single-core or multicore processor such asthose known under the trade name ARM Cortex by Texas Instruments. In oneaspect, the processor may be an LM4F230H5QR ARM Cortex-M4F ProcessorCore, available from Texas Instruments, for example, comprising anon-chip memory of 256 KB single-cycle flash memory, or othernon-volatile memory, up to 40 MHz, a prefetch buffer to improveperformance above 40 MHz, a 32 KB single-cycle serial random accessmemory (SRAM), an internal read-only memory (ROM) loaded withStellarisWare® software, a 2 KB electrically erasable programmableread-only memory (EEPROM), and/or one or more pulse width modulation(PWM) modules, one or more quadrature encoder inputs (QEI) analogs, oneor more 12-bit analog-to-digital converters (ADCs) with 12 analog inputchannels, details of which are available for the product datasheet.

In one aspect, the processor 244 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The system memory includes volatile memory and non-volatile memory. Thebasic input/output system (BIOS), containing the basic routines totransfer information between elements within the computer system, suchas during start-up, is stored in non-volatile memory. For example, thenon-volatile memory can include ROM, programmable ROM (PROM),electrically programmable ROM (EPROM), EEPROM, or flash memory. Volatilememory includes random-access memory (RAM), which acts as external cachememory. Moreover, RAM is available in many forms such as SRAM, dynamicRAM (DRAM), synchronous DRAM (SDRAM), double data rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), Synchlink DRAM (SLDRAM), and directRambus RAM (DRRAM).

The computer system 210 also includes removable/non-removable,volatile/non-volatile computer storage media, such as for example diskstorage. The disk storage includes, but is not limited to, devices likea magnetic disk drive, floppy disk drive, tape drive, Jaz drive, Zipdrive, LS-60 drive, flash memory card, or memory stick. In addition, thedisk storage can include storage media separately or in combination withother storage media including, but not limited to, an optical disc drivesuch as a compact disc ROM device (CD-ROM), compact disc recordabledrive (CD-R Drive), compact disc rewritable drive (CD-RW Drive), or adigital versatile disc ROM drive (DVD-ROM). To facilitate the connectionof the disk storage devices to the system bus, a removable ornon-removable interface may be employed.

It is to be appreciated that the computer system 210 includes softwarethat acts as an intermediary between users and the basic computerresources described in a suitable operating environment. Such softwareincludes an operating system. The operating system, which can be storedon the disk storage, acts to control and allocate resources of thecomputer system. System applications take advantage of the management ofresources by the operating system through program modules and programdata stored either in the system memory or on the disk storage. It is tobe appreciated that various components described herein can beimplemented with various operating systems or combinations of operatingsystems.

A user enters commands or information into the computer system 210through input device(s) coupled to the I/O interface 251. The inputdevices include, but are not limited to, a pointing device such as amouse, trackball, stylus, touch pad, keyboard, microphone, joystick,game pad, satellite dish, scanner, TV tuner card, digital camera,digital video camera, web camera, and the like. These and other inputdevices connect to the processor through the system bus via interfaceport(s). The interface port(s) include, for example, a serial port, aparallel port, a game port, and a USB. The output device(s) use some ofthe same types of ports as input device(s). Thus, for example, a USBport may be used to provide input to the computer system and to outputinformation from the computer system to an output device. An outputadapter is provided to illustrate that there are some output deviceslike monitors, displays, speakers, and printers, among other outputdevices that require special adapters. The output adapters include, byway of illustration and not limitation, video and sound cards thatprovide a means of connection between the output device and the systembus. It should be noted that other devices and/or systems of devices,such as remote computer(s), provide both input and output capabilities.

The computer system 210 can operate in a networked environment usinglogical connections to one or more remote computers, such as cloudcomputer(s), or local computers. The remote cloud computer(s) can be apersonal computer, server, router, network PC, workstation,microprocessor-based appliance, peer device, or other common networknode, and the like, and typically includes many or all of the elementsdescribed relative to the computer system. For purposes of brevity, onlya memory storage device is illustrated with the remote computer(s). Theremote computer(s) is logically connected to the computer system througha network interface and then physically connected via a communicationconnection. The network interface encompasses communication networkssuch as local area networks (LANs) and wide area networks (WANs). LANtechnologies include Fiber Distributed Data Interface (FDDI), CopperDistributed Data Interface (CDDI), Ethernet/IEEE 802.3, Token Ring/IEEE802.5 and the like. WAN technologies include, but are not limited to,point-to-point links, circuit-switching networks like IntegratedServices Digital Networks (ISDN) and variations thereon,packet-switching networks, and Digital Subscriber Lines (DSL).

In various aspects, the computer system 210 of FIG. 10, the imagingmodule 238 and/or visualization system 208, and/or the processor module232 of FIGS. 9-10, may comprise an image processor, image-processingengine, media processor, or any specialized digital signal processor(DSP) used for the processing of digital images. The image processor mayemploy parallel computing with single instruction, multiple data (SIMD)or multiple instruction, multiple data (MIMD) technologies to increasespeed and efficiency. The digital image-processing engine can perform arange of tasks. The image processor may be a system on a chip withmulticore processor architecture.

The communication connection(s) refers to the hardware/software employedto connect the network interface to the bus. While the communicationconnection is shown for illustrative clarity inside the computer system,it can also be external to the computer system 210. Thehardware/software necessary for connection to the network interfaceincludes, for illustrative purposes only, internal and externaltechnologies such as modems, including regular telephone-grade modems,cable modems, and DSL modems, ISDN adapters, and Ethernet cards.

FIG. 11 illustrates a functional block diagram of one aspect of a USBnetwork hub 300 device, in accordance with at least one aspect of thepresent disclosure. In the illustrated aspect, the USB network hubdevice 300 employs a TUSB2036 integrated circuit hub by TexasInstruments. The USB network hub 300 is a CMOS device that provides anupstream USB transceiver port 302 and up to three downstream USBtransceiver ports 304, 306, 308 in compliance with the USB 2.0specification. The upstream USB transceiver port 302 is a differentialroot data port comprising a differential data minus (DM0) input pairedwith a differential data plus (DP0) input. The three downstream USBtransceiver ports 304, 306, 308 are differential data ports where eachport includes differential data plus (DP1-DP3) outputs paired withdifferential data minus (DM1-DM3) outputs.

The USB network hub 300 device is implemented with a digital statemachine instead of a microcontroller, and no firmware programming isrequired. Fully compliant USB transceivers are integrated into thecircuit for the upstream USB transceiver port 302 and all downstream USBtransceiver ports 304, 306, 308. The downstream USB transceiver ports304, 306, 308 support both full-speed and low-speed devices byautomatically setting the slew rate according to the speed of the deviceattached to the ports. The USB network hub 300 device may be configuredeither in bus-powered or self-powered mode and includes a hub powerlogic 312 to manage power.

The USB network hub 300 device includes a serial interface engine 310(SIE). The SIE 310 is the front end of the USB network hub 300 hardwareand handles most of the protocol described in chapter 8 of the USBspecification. The SIE 310 typically comprehends signaling up to thetransaction level. The functions that it handles could include: packetrecognition, transaction sequencing, SOP, EOP, RESET, and RESUME signaldetection/generation, clock/data separation, non-return-to-zero invert(NRZI) data encoding/decoding and bit-stuffing, CRC generation andchecking (token and data), packet ID (PID) generation andchecking/decoding, and/or serial-parallel/parallel-serial conversion.The 310 receives a clock input 314 and is coupled to a suspend/resumelogic and frame timer 316 circuit and a hub repeater circuit 318 tocontrol communication between the upstream USB transceiver port 302 andthe downstream USB transceiver ports 304, 306, 308 through port logiccircuits 320, 322, 324. The SIE 310 is coupled to a command decoder 326via interface logic to control commands from a serial EEPROM via aserial EEPROM interface 330.

In various aspects, the USB network hub 300 can connect 127 functionsconfigured in up to six logical layers (tiers) to a single computer.Further, the USB network hub 300 can connect to all peripherals using astandardized four-wire cable that provides both communication and powerdistribution. The power configurations are bus-powered and self-poweredmodes. The USB network hub 300 may be configured to support four modesof power management: a bus-powered hub, with either individual-portpower management or ganged-port power management, and the self-poweredhub, with either individual-port power management or ganged-port powermanagement. In one aspect, using a USB cable, the USB network hub 300,the upstream USB transceiver port 302 is plugged into a USB hostcontroller, and the downstream USB transceiver ports 304, 306, 308 areexposed for connecting USB compatible devices, and so forth.

Surgical Instrument Hardware

FIG. 12 illustrates a logic diagram of a control system 470 of asurgical instrument or tool in accordance with one or more aspects ofthe present disclosure. The system 470 comprises a control circuit. Thecontrol circuit includes a microcontroller 461 comprising a processor462 and a memory 468. One or more of sensors 472, 474, 476, for example,provide real-time feedback to the processor 462. A motor 482, driven bya motor driver 492, operably couples a longitudinally movabledisplacement member to drive the I-beam knife element. A tracking system480 is configured to determine the position of the longitudinallymovable displacement member. The position information is provided to theprocessor 462, which can be programmed or configured to determine theposition of the longitudinally movable drive member as well as theposition of a firing member, firing bar, and I-beam knife element.Additional motors may be provided at the tool driver interface tocontrol I-beam firing, closure tube travel, shaft rotation, andarticulation. A display 473 displays a variety of operating conditionsof the instruments and may include touch screen functionality for datainput. Information displayed on the display 473 may be overlaid withimages acquired via endoscopic imaging modules.

In one aspect, the microcontroller 461 may be any single-core ormulticore processor such as those known under the trade name ARM Cortexby Texas Instruments. In one aspect, the main microcontroller 461 may bean LM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising an on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle SRAM, and internal ROM loaded with StellarisWare® software,a 2 KB EEPROM, one or more PWM modules, one or more QEI analogs, and/orone or more 12-bit ADCs with 12 analog input channels, details of whichare available for the product datasheet.

In one aspect, the microcontroller 461 may comprise a safety controllercomprising two controller-based families such as TMS570 and RM4x, knownunder the trade name Hercules ARM Cortex R4, also by Texas Instruments.The safety controller may be configured specifically for IEC 61508 andISO 26262 safety critical applications, among others, to provideadvanced integrated safety features while delivering scalableperformance, connectivity, and memory options.

The microcontroller 461 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the microcontroller 461 includes aprocessor 462 and a memory 468. The electric motor 482 may be a brusheddirect current (DC) motor with a gearbox and mechanical links to anarticulation or knife system. In one aspect, a motor driver 492 may bean A3941 available from Allegro Microsystems, Inc. Other motor driversmay be readily substituted for use in the tracking system 480 comprisingan absolute positioning system. A detailed description of an absolutepositioning system is described in U.S. Patent Application PublicationNo. 2017/0296213, titled SYSTEMS AND METHODS FOR CONTROLLING A SURGICALSTAPLING AND CUTTING INSTRUMENT, which published on Oct. 19, 2017, whichis herein incorporated by reference in its entirety.

The microcontroller 461 may be programmed to provide precise controlover the speed and position of displacement members and articulationsystems. The microcontroller 461 may be configured to compute a responsein the software of the microcontroller 461. The computed response iscompared to a measured response of the actual system to obtain an“observed” response, which is used for actual feedback decisions. Theobserved response is a favorable, tuned value that balances the smooth,continuous nature of the simulated response with the measured response,which can detect outside influences on the system.

In one aspect, the motor 482 may be controlled by the motor driver 492and can be employed by the firing system of the surgical instrument ortool. In various forms, the motor 482 may be a brushed DC driving motorhaving a maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 482 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 492 may comprise an H-bridge drivercomprising field-effect transistors (FETs), for example. The motor 482can be powered by a power assembly releasably mounted to the handleassembly or tool housing for supplying control power to the surgicalinstrument or tool. The power assembly may comprise a battery which mayinclude a number of battery cells connected in series that can be usedas the power source to power the surgical instrument or tool. In certaincircumstances, the battery cells of the power assembly may bereplaceable and/or rechargeable. In at least one example, the batterycells can be lithium-ion batteries which can be couplable to andseparable from the power assembly.

The motor driver 492 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 492 is a full-bridge controller for usewith external N-channel power metal-oxide semiconductor field-effecttransistors (MOSFETs) specifically designed for inductive loads, such asbrush DC motors. The driver 492 comprises a unique charge pump regulatorthat provides full (>10 V) gate drive for battery voltages down to 7 Vand allows the A3941 to operate with a reduced gate drive, down to 5.5V. A bootstrap capacitor may be employed to provide the above batterysupply voltage required for N-channel MOSFETs. An internal charge pumpfor the high-side drive allows DC (100% duty cycle) operation. The fullbridge can be driven in fast or slow decay modes using diode orsynchronous rectification. In the slow decay mode, current recirculationcan be through the high-side or the lowside FETs. The power FETs areprotected from shoot-through by resistor-adjustable dead time.Integrated diagnostics provide indications of undervoltage,overtemperature, and power bridge faults and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the tracking system480 comprising an absolute positioning system.

The tracking system 480 comprises a controlled motor drive circuitarrangement comprising a position sensor 472, in accordance with atleast one aspect of this disclosure. The position sensor 472 for anabsolute positioning system provides a unique position signalcorresponding to the location of a displacement member. In one aspect,the displacement member represents a longitudinally movable drive membercomprising a rack of drive teeth for meshing engagement with acorresponding drive gear of a gear reducer assembly. In other aspects,the displacement member represents the firing member, which could beadapted and configured to include a rack of drive teeth. In yet anotheraspect, the displacement member represents a firing bar or the I-beam,each of which can be adapted and configured to include a rack of driveteeth. Accordingly, as used herein, the term displacement member is usedgenerically to refer to any movable member of the surgical instrument ortool such as the drive member, the firing member, the firing bar, theI-beam, or any element that can be displaced. In one aspect, thelongitudinally movable drive member is coupled to the firing member, thefiring bar, and the I-beam. Accordingly, the absolute positioning systemcan, in effect, track the linear displacement of the I-beam by trackingthe linear displacement of the longitudinally movable drive member. Invarious other aspects, the displacement member may be coupled to anyposition sensor 472 suitable for measuring linear displacement. Thus,the longitudinally movable drive member, the firing member, the firingbar, or the I-beam, or combinations thereof, may be coupled to anysuitable linear displacement sensor. Linear displacement sensors mayinclude contact or non-contact displacement sensors. Linear displacementsensors may comprise linear variable differential transformers (LVDT),differential variable reluctance transducers (DVRT), a slidepotentiometer, a magnetic sensing system comprising a movable magnet anda series of linearly arranged Hall effect sensors, a magnetic sensingsystem comprising a fixed magnet and a series of movable, linearlyarranged Hall effect sensors, an optical sensing system comprising amovable light source and a series of linearly arranged photo diodes orphoto detectors, an optical sensing system comprising a fixed lightsource and a series of movable linearly, arranged photo diodes or photodetectors, or any combination thereof.

The electric motor 482 can include a rotatable shaft that operablyinterfaces with a gear assembly that is mounted in meshing engagementwith a set, or rack, of drive teeth on the displacement member. A sensorelement may be operably coupled to a gear assembly such that a singlerevolution of the position sensor 472 element corresponds to some linearlongitudinal translation of the displacement member. An arrangement ofgearing and sensors can be connected to the linear actuator, via a rackand pinion arrangement, or a rotary actuator, via a spur gear or otherconnection. A power source supplies power to the absolute positioningsystem and an output indicator may display the output of the absolutepositioning system. The displacement member represents thelongitudinally movable drive member comprising a rack of drive teethformed thereon for meshing engagement with a corresponding drive gear ofthe gear reducer assembly. The displacement member represents thelongitudinally movable firing member, firing bar, I-beam, orcombinations thereof.

A single revolution of the sensor element associated with the positionsensor 472 is equivalent to a longitudinal linear displacement d1 of theof the displacement member, where d1 is the longitudinal linear distancethat the displacement member moves from point “a” to point “b” after asingle revolution of the sensor element coupled to the displacementmember. The sensor arrangement may be connected via a gear reductionthat results in the position sensor 472 completing one or morerevolutions for the full stroke of the displacement member. The positionsensor 472 may complete multiple revolutions for the full stroke of thedisplacement member.

A series of switches, where n is an integer greater than one, may beemployed alone or in combination with a gear reduction to provide aunique position signal for more than one revolution of the positionsensor 472. The state of the switches are fed back to themicrocontroller 461 that applies logic to determine a unique positionsignal corresponding to the longitudinal linear displacement d1+d2+ . .. dn of the displacement member. The output of the position sensor 472is provided to the microcontroller 461. The position sensor 472 of thesensor arrangement may comprise a magnetic sensor, an analog rotarysensor like a potentiometer, or an array of analog Hall-effect elements,which output a unique combination of position signals or values.

The position sensor 472 may comprise any number of magnetic sensingelements, such as, for example, magnetic sensors classified according towhether they measure the total magnetic field or the vector componentsof the magnetic field. The techniques used to produce both types ofmagnetic sensors encompass many aspects of physics and electronics. Thetechnologies used for magnetic field sensing include search coil,fluxgate, optically pumped, nuclear precession, SQUID, Hall-effect,anisotropic magnetoresistance, giant magnetoresistance, magnetic tunneljunctions, giant magnetoimpedance, magnetostrictive/piezoelectriccomposites, magnetodiode, magnetotransistor, fiber-optic, magneto-optic,and microelectromechanical systems-based magnetic sensors, among others.

In one aspect, the position sensor 472 for the tracking system 480comprising an absolute positioning system comprises a magnetic rotaryabsolute positioning system. The position sensor 472 may be implementedas an AS5055EQFT single-chip magnetic rotary position sensor availablefrom Austria Microsystems, AG. The position sensor 472 is interfacedwith the microcontroller 461 to provide an absolute positioning system.The position sensor 472 is a low-voltage and low-power component andincludes four Hall-effect elements in an area of the position sensor 472that is located above a magnet. A high-resolution ADC and a smart powermanagement controller are also provided on the chip. A coordinaterotation digital computer (CORDIC) processor, also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface, such as a serial peripheral interface (SPI) interface, to themicrocontroller 461. The position sensor 472 provides 12 or 14 bits ofresolution. The position sensor 472 may be an AS5055 chip provided in asmall QFN 16-pin 4×4×0.85 mm package.

The tracking system 480 comprising an absolute positioning system maycomprise and/or be programmed to implement a feedback controller, suchas a PID, state feedback, and adaptive controller. A power sourceconverts the signal from the feedback controller into a physical inputto the system: in this case the voltage. Other examples include a PWM ofthe voltage, current, and force. Other sensor(s) may be provided tomeasure physical parameters of the physical system in addition to theposition measured by the position sensor 472. In some aspects, the othersensor(s) can include sensor arrangements such as those described inU.S. Pat. No. 9,345,481, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSORSYSTEM, which issued on May 24, 2016, which is herein incorporated byreference in its entirety; U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM,which published on Sep. 18, 2014, which is herein incorporated byreference in its entirety; and U.S. patent application Ser. No.15/628,175, titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OFA SURGICAL STAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, whichis herein incorporated by reference in its entirety. In a digital signalprocessing system, an absolute positioning system is coupled to adigital data acquisition system where the output of the absolutepositioning system will have a finite resolution and sampling frequency.The absolute positioning system may comprise a compare-and-combinecircuit to combine a computed response with a measured response usingalgorithms, such as a weighted average and a theoretical control loop,that drive the computed response towards the measured response. Thecomputed response of the physical system takes into account propertieslike mass, inertial, viscous friction, inductance resistance, etc., topredict what the states and outputs of the physical system will be byknowing the input.

The absolute positioning system provides an absolute position of thedisplacement member upon power-up of the instrument, without retractingor advancing the displacement member to a reset (zero or home) positionas may be required with conventional rotary encoders that merely countthe number of steps forwards or backwards that the motor 482 has takento infer the position of a device actuator, drive bar, knife, or thelike.

A sensor 474, such as, for example, a strain gauge or a micro-straingauge, is configured to measure one or more parameters of the endeffector, such as, for example, the amplitude of the strain exerted onthe anvil during a clamping operation, which can be indicative of theclosure forces applied to the anvil. The measured strain is converted toa digital signal and provided to the processor 462. Alternatively, or inaddition to the sensor 474, a sensor 476, such as, for example, a loadsensor, can measure the closure force applied by the closure drivesystem to the anvil. The sensor 476, such as, for example, a loadsensor, can measure the firing force applied to an I-beam in a firingstroke of the surgical instrument or tool. The I-beam is configured toengage a wedge sled, which is configured to upwardly cam staple driversto force out staples into deforming contact with an anvil. The I-beamalso includes a sharpened cutting edge that can be used to sever tissueas the I-beam is advanced distally by the firing bar. Alternatively, acurrent sensor 478 can be employed to measure the current drawn by themotor 482. The force required to advance the firing member cancorrespond to the current drawn by the motor 482, for example. Themeasured force is converted to a digital signal and provided to theprocessor 462.

In one form, the strain gauge sensor 474 can be used to measure theforce applied to the tissue by the end effector. A strain gauge can becoupled to the end effector to measure the force on the tissue beingtreated by the end effector. A system for measuring forces applied tothe tissue grasped by the end effector comprises a strain gauge sensor474, such as, for example, a micro-strain gauge, that is configured tomeasure one or more parameters of the end effector, for example. In oneaspect, the strain gauge sensor 474 can measure the amplitude ormagnitude of the strain exerted on a jaw member of an end effectorduring a clamping operation, which can be indicative of the tissuecompression. The measured strain is converted to a digital signal andprovided to a processor 462 of the microcontroller 461. A load sensor476 can measure the force used to operate the knife element, forexample, to cut the tissue captured between the anvil and the staplecartridge. A magnetic field sensor can be employed to measure thethickness of the captured tissue. The measurement of the magnetic fieldsensor also may be converted to a digital signal and provided to theprocessor 462.

The measurements of the tissue compression, the tissue thickness, and/orthe force required to close the end effector on the tissue, asrespectively measured by the sensors 474, 476, can be used by themicrocontroller 461 to characterize the selected position of the firingmember and/or the corresponding value of the speed of the firing member.In one instance, a memory 468 may store a technique, an equation, and/ora lookup table which can be employed by the microcontroller 461 in theassessment.

The control system 470 of the surgical instrument or tool also maycomprise wired or wireless communication circuits to communicate withthe modular communication hub as shown in FIGS. 8-11.

FIG. 13 illustrates a control circuit 500 configured to control aspectsof the surgical instrument or tool, in accordance with at least oneaspect of this disclosure. The control circuit 500 can be configured toimplement various processes described herein. The control circuit 500may comprise a microcontroller comprising one or more processors 502(e.g., microprocessor, microcontroller) coupled to at least one memorycircuit 504. The memory circuit 504 stores machine-executableinstructions that, when executed by the processor 502, cause theprocessor 502 to execute machine instructions to implement variousprocesses described herein. The processor 502 may be any one of a numberof single-core or multicore processors known in the art. The memorycircuit 504 may comprise volatile and non-volatile storage media. Theprocessor 502 may include an instruction processing unit 506 and anarithmetic unit 508. The instruction processing unit may be configuredto receive instructions from the memory circuit 504 of this disclosure.

FIG. 14 illustrates a combinational logic circuit 510 configured tocontrol aspects of the surgical instrument or tool, in accordance withat least one aspect of this disclosure. The combinational logic circuit510 can be configured to implement various processes described herein.The combinational logic circuit 510 may comprise a finite state machinecomprising a combinational logic 512 configured to receive dataassociated with the surgical instrument or tool at an input 514, processthe data by the combinational logic 512, and provide an output 516.

FIG. 15 illustrates a sequential logic circuit 520 configured to controlaspects of the surgical instrument or tool, in accordance with at leastone aspect of this disclosure. The sequential logic circuit 520 or thecombinational logic 522 can be configured to implement various processesdescribed herein. The sequential logic circuit 520 may comprise a finitestate machine. The sequential logic circuit 520 may comprise acombinational logic 522, at least one memory circuit 524, and a clock529, for example. The at least one memory circuit 524 can store acurrent state of the finite state machine. In certain instances, thesequential logic circuit 520 may be synchronous or asynchronous. Thecombinational logic 522 is configured to receive data associated withthe surgical instrument or tool from an input 526, process the data bythe combinational logic 522, and provide an output 528. In otheraspects, the circuit may comprise a combination of a processor (e.g.,processor 502, FIG. 13) and a finite state machine to implement variousprocesses herein. In other aspects, the finite state machine maycomprise a combination of a combinational logic circuit (e.g.,combinational logic circuit 510, FIG. 14) and the sequential logiccircuit 520.

FIG. 16 illustrates a surgical instrument or tool comprising a pluralityof motors which can be activated to perform various functions. Incertain instances, a first motor can be activated to perform a firstfunction, a second motor can be activated to perform a second function,a third motor can be activated to perform a third function, a fourthmotor can be activated to perform a fourth function, and so on. Incertain instances, the plurality of motors of robotic surgicalinstrument 600 can be individually activated to cause firing, closure,and/or articulation motions in the end effector. The firing, closure,and/or articulation motions can be transmitted to the end effectorthrough a shaft assembly, for example.

In certain instances, the surgical instrument system or tool may includea firing motor 602. The firing motor 602 may be operably coupled to afiring motor drive assembly 604 which can be configured to transmitfiring motions, generated by the motor 602 to the end effector, inparticular to displace the I-beam element. In certain instances, thefiring motions generated by the motor 602 may cause the staples to bedeployed from the staple cartridge into tissue captured by the endeffector and/or the cutting edge of the I-beam element to be advanced tocut the captured tissue, for example. The I-beam element may beretracted by reversing the direction of the motor 602.

In certain instances, the surgical instrument or tool may include aclosure motor 603. The closure motor 603 may be operably coupled to aclosure motor drive assembly 605 which can be configured to transmitclosure motions, generated by the motor 603 to the end effector, inparticular to displace a closure tube to close the anvil and compresstissue between the anvil and the staple cartridge. The closure motionsmay cause the end effector to transition from an open configuration toan approximated configuration to capture tissue, for example. The endeffector may be transitioned to an open position by reversing thedirection of the motor 603.

In certain instances, the surgical instrument or tool may include one ormore articulation motors 606 a, 606 b, for example. The motors 606 a,606 b may be operably coupled to respective articulation motor driveassemblies 608 a, 608 b, which can be configured to transmitarticulation motions generated by the motors 606 a, 606 b to the endeffector. In certain instances, the articulation motions may cause theend effector to articulate relative to the shaft, for example.

As described above, the surgical instrument or tool may include aplurality of motors which may be configured to perform variousindependent functions. In certain instances, the plurality of motors ofthe surgical instrument or tool can be individually or separatelyactivated to perform one or more functions while the other motors remaininactive. For example, the articulation motors 606 a, 606 b can beactivated to cause the end effector to be articulated while the firingmotor 602 remains inactive. Alternatively, the firing motor 602 can beactivated to fire the plurality of staples, and/or to advance thecutting edge, while the articulation motor 606 remains inactive.Furthermore, the closure motor 603 may be activated simultaneously withthe firing motor 602 to cause the closure tube and the I-beam element toadvance distally as described in more detail hereinbelow.

In certain instances, the surgical instrument or tool may include acommon control module 610 which can be employed with a plurality ofmotors of the surgical instrument or tool. In certain instances, thecommon control module 610 may accommodate one of the plurality of motorsat a time. For example, the common control module 610 can be couplableto and separable from the plurality of motors of the robotic surgicalinstrument individually. In certain instances, a plurality of the motorsof the surgical instrument or tool may share one or more common controlmodules such as the common control module 610. In certain instances, aplurality of motors of the surgical instrument or tool can beindividually and selectively engaged with the common control module 610.In certain instances, the common control module 610 can be selectivelyswitched from interfacing with one of a plurality of motors of thesurgical instrument or tool to interfacing with another one of theplurality of motors of the surgical instrument or tool.

In at least one example, the common control module 610 can beselectively switched between operable engagement with the articulationmotors 606 a, 606 b and operable engagement with either the firing motor602 or the closure motor 603. In at least one example, as illustrated inFIG. 16, a switch 614 can be moved or transitioned between a pluralityof positions and/or states. In a first position 616, the switch 614 mayelectrically couple the common control module 610 to the firing motor602; in a second position 617, the switch 614 may electrically couplethe common control module 610 to the closure motor 603; in a thirdposition 618 a, the switch 614 may electrically couple the commoncontrol module 610 to the first articulation motor 606 a; and in afourth position 618 b, the switch 614 may electrically couple the commoncontrol module 610 to the second articulation motor 606 b, for example.In certain instances, separate common control modules 610 can beelectrically coupled to the firing motor 602, the closure motor 603, andthe articulations motor 606 a, 606 b at the same time. In certaininstances, the switch 614 may be a mechanical switch, anelectromechanical switch, a solid-state switch, or any suitableswitching mechanism.

Each of the motors 602, 603, 606 a, 606 b may comprise a torque sensorto measure the output torque on the shaft of the motor. The force on anend effector may be sensed in any conventional manner, such as by forcesensors on the outer sides of the jaws or by a torque sensor for themotor actuating the jaws.

In various instances, as illustrated in FIG. 16, the common controlmodule 610 may comprise a motor driver 626 which may comprise one ormore H-Bridge FETs. The motor driver 626 may modulate the powertransmitted from a power source 628 to a motor coupled to the commoncontrol module 610 based on input from a microcontroller 620 (the“controller”), for example. In certain instances, the microcontroller620 can be employed to determine the current drawn by the motor, forexample, while the motor is coupled to the common control module 610, asdescribed above.

In certain instances, the microcontroller 620 may include amicroprocessor 622 (the “processor”) and one or more non-transitorycomputer-readable mediums or memory units 624 (the “memory”). In certaininstances, the memory 624 may store various program instructions, whichwhen executed may cause the processor 622 to perform a plurality offunctions and/or calculations described herein. In certain instances,one or more of the memory units 624 may be coupled to the processor 622,for example.

In certain instances, the power source 628 can be employed to supplypower to the microcontroller 620, for example. In certain instances, thepower source 628 may comprise a battery (or “battery pack” or “powerpack”), such as a lithium-ion battery, for example. In certaininstances, the battery pack may be configured to be releasably mountedto a handle for supplying power to the surgical instrument 600. A numberof battery cells connected in series may be used as the power source628. In certain instances, the power source 628 may be replaceableand/or rechargeable, for example.

In various instances, the processor 622 may control the motor driver 626to control the position, direction of rotation, and/or velocity of amotor that is coupled to the common control module 610. In certaininstances, the processor 622 can signal the motor driver 626 to stopand/or disable a motor that is coupled to the common control module 610.It should be understood that the term “processor” as used hereinincludes any suitable microprocessor, microcontroller, or other basiccomputing device that incorporates the functions of a computer's centralprocessing unit (CPU) on an integrated circuit or, at most, a fewintegrated circuits. The processor is a multipurpose, programmabledevice that accepts digital data as input, processes it according toinstructions stored in its memory, and provides results as output. It isan example of sequential digital logic, as it has internal memory.Processors operate on numbers and symbols represented in the binarynumeral system.

In one instance, the processor 622 may be any single-core or multicoreprocessor such as those known under the trade name ARM Cortex by TexasInstruments. In certain instances, the microcontroller 620 may be an LM4F230H5QR, available from Texas Instruments, for example. In at leastone example, the Texas Instruments LM4F230H5QR is an ARM Cortex-M4FProcessor Core comprising an on-chip memory of 256 KB single-cycle flashmemory, or other non-volatile memory, up to 40 MHz, a prefetch buffer toimprove performance above 40 MHz, a 32 KB single-cycle SRAM, an internalROM loaded with StellarisWare® software, a 2 KB EEPROM, one or more PWMmodules, one or more QEI analogs, one or more 12-bit ADCs with 12 analoginput channels, among other features that are readily available for theproduct datasheet. Other microcontrollers may be readily substituted foruse with the module 4410. Accordingly, the present disclosure should notbe limited in this context.

In certain instances, the memory 624 may include program instructionsfor controlling each of the motors of the surgical instrument 600 thatare couplable to the common control module 610. For example, the memory624 may include program instructions for controlling the firing motor602, the closure motor 603, and the articulation motors 606 a, 606 b.Such program instructions may cause the processor 622 to control thefiring, closure, and articulation functions in accordance with inputsfrom algorithms or control programs of the surgical instrument or tool.

In certain instances, one or more mechanisms and/or sensors such as, forexample, sensors 630 can be employed to alert the processor 622 to theprogram instructions that should be used in a particular setting. Forexample, the sensors 630 may alert the processor 622 to use the programinstructions associated with firing, closing, and articulating the endeffector. In certain instances, the sensors 630 may comprise positionsensors which can be employed to sense the position of the switch 614,for example. Accordingly, the processor 622 may use the programinstructions associated with firing the I-beam of the end effector upondetecting, through the sensors 630 for example, that the switch 614 isin the first position 616; the processor 622 may use the programinstructions associated with closing the anvil upon detecting, throughthe sensors 630 for example, that the switch 614 is in the secondposition 617; and the processor 622 may use the program instructionsassociated with articulating the end effector upon detecting, throughthe sensors 630 for example, that the switch 614 is in the third orfourth position 618 a, 618 b.

FIG. 17 is a schematic diagram of a robotic surgical instrument 700configured to operate a surgical tool described herein, in accordancewith at least one aspect of this disclosure. The robotic surgicalinstrument 700 may be programmed or configured to controldistal/proximal translation of a displacement member, distal/proximaldisplacement of a closure tube, shaft rotation, and articulation, eitherwith single or multiple articulation drive links. In one aspect, thesurgical instrument 700 may be programmed or configured to individuallycontrol a firing member, a closure member, a shaft member, and/or one ormore articulation members. The surgical instrument 700 comprises acontrol circuit 710 configured to control motor-driven firing members,closure members, shaft members, and/or one or more articulation members.

In one aspect, the robotic surgical instrument 700 comprises a controlcircuit 710 configured to control an anvil 716 and an I-beam 714(including a sharp cutting edge) portion of an end effector 702, aremovable staple cartridge 718, a shaft 740, and one or morearticulation members 742 a, 742 b via a plurality of motors 704 a-704 e.A position sensor 734 may be configured to provide position feedback ofthe I-beam 714 to the control circuit 710. Other sensors 738 may beconfigured to provide feedback to the control circuit 710. Atimer/counter 731 provides timing and counting information to thecontrol circuit 710. An energy source 712 may be provided to operate themotors 704 a-704 e, and a current sensor 736 provides motor currentfeedback to the control circuit 710. The motors 704 a-704 e can beoperated individually by the control circuit 710 in an open-loop orclosed-loop feedback control.

In one aspect, the control circuit 710 may comprise one or moremicrocontrollers, microprocessors, or other suitable processors forexecuting instructions that cause the processor or processors to performone or more tasks. In one aspect, a timer/counter 731 provides an outputsignal, such as the elapsed time or a digital count, to the controlcircuit 710 to correlate the position of the I-beam 714 as determined bythe position sensor 734 with the output of the timer/counter 731 suchthat the control circuit 710 can determine the position of the I-beam714 at a specific time (t) relative to a starting position or the time(t) when the I-beam 714 is at a specific position relative to a startingposition. The timer/counter 731 may be configured to measure elapsedtime, count external events, or time external events.

In one aspect, the control circuit 710 may be programmed to controlfunctions of the end effector 702 based on one or more tissueconditions. The control circuit 710 may be programmed to sense tissueconditions, such as thickness, either directly or indirectly, asdescribed herein. The control circuit 710 may be programmed to select afiring control program or closure control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 710 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 710 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power. A closure control program may control theclosure force applied to the tissue by the anvil 716. Other controlprograms control the rotation of the shaft 740 and the articulationmembers 742 a, 742 b.

In one aspect, the control circuit 710 may generate motor set pointsignals. The motor set point signals may be provided to various motorcontrollers 708 a-708 e. The motor controllers 708 a-708 e may compriseone or more circuits configured to provide motor drive signals to themotors 704 a-704 e to drive the motors 704 a-704 e as described herein.In some examples, the motors 704 a-704 e may be brushed DC electricmotors. For example, the velocity of the motors 704 a-704 e may beproportional to the respective motor drive signals. In some examples,the motors 704 a-704 e may be brushless DC electric motors, and therespective motor drive signals may comprise a PWM signal provided to oneor more stator windings of the motors 704 a-704 e. Also, in someexamples, the motor controllers 708 a-708 e may be omitted and thecontrol circuit 710 may generate the motor drive signals directly.

In one aspect, the control circuit 710 may initially operate each of themotors 704 a-704 e in an open-loop configuration for a first open-loopportion of a stroke of the displacement member. Based on the response ofthe robotic surgical instrument 700 during the open-loop portion of thestroke, the control circuit 710 may select a firing control program in aclosed-loop configuration. The response of the instrument may include atranslation distance of the displacement member during the open-loopportion, a time elapsed during the open-loop portion, the energyprovided to one of the motors 704 a-704 e during the open-loop portion,a sum of pulse widths of a motor drive signal, etc. After the open-loopportion, the control circuit 710 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during a closed-loop portion of the stroke, the controlcircuit 710 may modulate one of the motors 704 a-704 e based ontranslation data describing a position of the displacement member in aclosed-loop manner to translate the displacement member at a constantvelocity.

In one aspect, the motors 704 a-704 e may receive power from an energysource 712. The energy source 712 may be a DC power supply driven by amain alternating current power source, a battery, a super capacitor, orany other suitable energy source. The motors 704 a-704 e may bemechanically coupled to individual movable mechanical elements such asthe I-beam 714, anvil 716, shaft 740, articulation 742 a, andarticulation 742 b via respective transmissions 706 a-706 e. Thetransmissions 706 a-706 e may include one or more gears or other linkagecomponents to couple the motors 704 a-704 e to movable mechanicalelements. A position sensor 734 may sense a position of the I-beam 714.The position sensor 734 may be or include any type of sensor that iscapable of generating position data that indicate a position of theI-beam 714. In some examples, the position sensor 734 may include anencoder configured to provide a series of pulses to the control circuit710 as the I-beam 714 translates distally and proximally. The controlcircuit 710 may track the pulses to determine the position of the I-beam714. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 714. Also, in someexamples, the position sensor 734 may be omitted. Where any of themotors 704 a-704 e is a stepper motor, the control circuit 710 may trackthe position of the I-beam 714 by aggregating the number and directionof steps that the motor 704 has been instructed to execute. The positionsensor 734 may be located in the end effector 702 or at any otherportion of the instrument. The outputs of each of the motors 704 a-704 einclude a torque sensor 744 a-744 e to sense force and have an encoderto sense rotation of the drive shaft.

In one aspect, the control circuit 710 is configured to drive a firingmember such as the I-beam 714 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 a,which provides a drive signal to the motor 704 a. The output shaft ofthe motor 704 a is coupled to a torque sensor 744 a. The torque sensor744 a is coupled to a transmission 706 a which is coupled to the I-beam714. The transmission 706 a comprises movable mechanical elements suchas rotating elements and a firing member to control the movement of theI-beam 714 distally and proximally along a longitudinal axis of the endeffector 702. In one aspect, the motor 704 a may be coupled to the knifegear assembly, which includes a knife gear reduction set that includes afirst knife drive gear and a second knife drive gear. A torque sensor744 a provides a firing force feedback signal to the control circuit710. The firing force signal represents the force required to fire ordisplace the I-beam 714. A position sensor 734 may be configured toprovide the position of the I-beam 714 along the firing stroke or theposition of the firing member as a feedback signal to the controlcircuit 710. The end effector 702 may include additional sensors 738configured to provide feedback signals to the control circuit 710. Whenready to use, the control circuit 710 may provide a firing signal to themotor control 708 a. In response to the firing signal, the motor 704 amay drive the firing member distally along the longitudinal axis of theend effector 702 from a proximal stroke start position to a stroke endposition distal to the stroke start position. As the firing membertranslates distally, an I-beam 714, with a cutting element positioned ata distal end, advances distally to cut tissue located between the staplecartridge 718 and the anvil 716.

In one aspect, the control circuit 710 is configured to drive a closuremember such as the anvil 716 portion of the end effector 702. Thecontrol circuit 710 provides a motor set point to a motor control 708 b,which provides a drive signal to the motor 704 b. The output shaft ofthe motor 704 b is coupled to a torque sensor 744 b. The torque sensor744 b is coupled to a transmission 706 b which is coupled to the anvil716. The transmission 706 b comprises movable mechanical elements suchas rotating elements and a closure member to control the movement of theanvil 716 from the open and closed positions. In one aspect, the motor704 b is coupled to a closure gear assembly, which includes a closurereduction gear set that is supported in meshing engagement with theclosure spur gear. The torque sensor 744 b provides a closure forcefeedback signal to the control circuit 710. The closure force feedbacksignal represents the closure force applied to the anvil 716. Theposition sensor 734 may be configured to provide the position of theclosure member as a feedback signal to the control circuit 710.Additional sensors 738 in the end effector 702 may provide the closureforce feedback signal to the control circuit 710. The pivotable anvil716 is positioned opposite the staple cartridge 718. When ready to use,the control circuit 710 may provide a closure signal to the motorcontrol 708 b. In response to the closure signal, the motor 704 badvances a closure member to grasp tissue between the anvil 716 and thestaple cartridge 718.

In one aspect, the control circuit 710 is configured to rotate a shaftmember such as the shaft 740 to rotate the end effector 702. The controlcircuit 710 provides a motor set point to a motor control 708 c, whichprovides a drive signal to the motor 704 c. The output shaft of themotor 704 c is coupled to a torque sensor 744 c. The torque sensor 744 cis coupled to a transmission 706 c which is coupled to the shaft 740.The transmission 706 c comprises movable mechanical elements such asrotating elements to control the rotation of the shaft 740 clockwise orcounterclockwise up to and over 360°. In one aspect, the motor 704 c iscoupled to the rotational transmission assembly, which includes a tubegear segment that is formed on (or attached to) the proximal end of theproximal closure tube for operable engagement by a rotational gearassembly that is operably supported on the tool mounting plate. Thetorque sensor 744 c provides a rotation force feedback signal to thecontrol circuit 710. The rotation force feedback signal represents therotation force applied to the shaft 740. The position sensor 734 may beconfigured to provide the position of the closure member as a feedbacksignal to the control circuit 710. Additional sensors 738 such as ashaft encoder may provide the rotational position of the shaft 740 tothe control circuit 710.

In one aspect, the control circuit 710 is configured to articulate theend effector 702. The control circuit 710 provides a motor set point toa motor control 708 d, which provides a drive signal to the motor 704 d.The output shaft of the motor 704 d is coupled to a torque sensor 744 d.The torque sensor 744 d is coupled to a transmission 706 d which iscoupled to an articulation member 742 a. The transmission 706 dcomprises movable mechanical elements such as articulation elements tocontrol the articulation of the end effector 702 ±65°. In one aspect,the motor 704 d is coupled to an articulation nut, which is rotatablyjournaled on the proximal end portion of the distal spine portion and isrotatably driven thereon by an articulation gear assembly. The torquesensor 744 d provides an articulation force feedback signal to thecontrol circuit 710. The articulation force feedback signal representsthe articulation force applied to the end effector 702. Sensors 738,such as an articulation encoder, may provide the articulation positionof the end effector 702 to the control circuit 710.

In another aspect, the articulation function of the robotic surgicalsystem 700 may comprise two articulation members, or links, 742 a, 742b. These articulation members 742 a, 742 b are driven by separate diskson the robot interface (the rack) which are driven by the two motors 708d, 708 e. When the separate firing motor 704 a is provided, each ofarticulation links 742 a, 742 b can be antagonistically driven withrespect to the other link in order to provide a resistive holding motionand a load to the head when it is not moving and to provide anarticulation motion as the head is articulated. The articulation members742 a, 742 b attach to the head at a fixed radius as the head isrotated. Accordingly, the mechanical advantage of the push-and-pull linkchanges as the head is rotated. This change in the mechanical advantagemay be more pronounced with other articulation link drive systems.

In one aspect, the one or more motors 704 a-704 e may comprise a brushedDC motor with a gearbox and mechanical links to a firing member, closuremember, or articulation member. Another example includes electric motors704 a-704 e that operate the movable mechanical elements such as thedisplacement member, articulation links, closure tube, and shaft. Anoutside influence is an unmeasured, unpredictable influence of thingslike tissue, surrounding bodies, and friction on the physical system.Such outside influence can be referred to as drag, which acts inopposition to one of electric motors 704 a-704 e. The outside influence,such as drag, may cause the operation of the physical system to deviatefrom a desired operation of the physical system.

In one aspect, the position sensor 734 may be implemented as an absolutepositioning system. In one aspect, the position sensor 734 may comprisea magnetic rotary absolute positioning system implemented as anAS5055EQFT single-chip magnetic rotary position sensor available fromAustria Microsystems, AG. The position sensor 734 may interface with thecontrol circuit 710 to provide an absolute positioning system. Theposition may include multiple Hall-effect elements located above amagnet and coupled to a CORDIC processor, also known as thedigit-by-digit method and Volder's algorithm, that is provided toimplement a simple and efficient algorithm to calculate hyperbolic andtrigonometric functions that require only addition, subtraction,bitshift, and table lookup operations.

In one aspect, the control circuit 710 may be in communication with oneor more sensors 738. The sensors 738 may be positioned on the endeffector 702 and adapted to operate with the robotic surgical instrument700 to measure the various derived parameters such as the gap distanceversus time, tissue compression versus time, and anvil strain versustime. The sensors 738 may comprise a magnetic sensor, a magnetic fieldsensor, a strain gauge, a load cell, a pressure sensor, a force sensor,a torque sensor, an inductive sensor such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor for measuring one or more parameters of the endeffector 702. The sensors 738 may include one or more sensors. Thesensors 738 may be located on the staple cartridge 718 deck to determinetissue location using segmented electrodes. The torque sensors 744 a-744e may be configured to sense force such as firing force, closure force,and/or articulation force, among others. Accordingly, the controlcircuit 710 can sense (1) the closure load experienced by the distalclosure tube and its position, (2) the firing member at the rack and itsposition, (3) what portion of the staple cartridge 718 has tissue on it,and (4) the load and position on both articulation rods.

In one aspect, the one or more sensors 738 may comprise a strain gauge,such as a micro-strain gauge, configured to measure the magnitude of thestrain in the anvil 716 during a clamped condition. The strain gaugeprovides an electrical signal whose amplitude varies with the magnitudeof the strain. The sensors 738 may comprise a pressure sensor configuredto detect a pressure generated by the presence of compressed tissuebetween the anvil 716 and the staple cartridge 718. The sensors 738 maybe configured to detect impedance of a tissue section located betweenthe anvil 716 and the staple cartridge 718 that is indicative of thethickness and/or fullness of tissue located therebetween.

In one aspect, the sensors 738 may be implemented as one or more limitswitches, electromechanical devices, solid-state switches, Hall-effectdevices, magneto-resistive (MR) devices, giant magneto-resistive (GMR)devices, magnetometers, among others. In other implementations, thesensors 738 may be implemented as solid-state switches that operateunder the influence of light, such as optical sensors, IR sensors,ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors738 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the sensors 738 may be configured to measure forcesexerted on the anvil 716 by the closure drive system. For example, oneor more sensors 738 can be at an interaction point between the closuretube and the anvil 716 to detect the closure forces applied by theclosure tube to the anvil 716. The forces exerted on the anvil 716 canbe representative of the tissue compression experienced by the tissuesection captured between the anvil 716 and the staple cartridge 718. Theone or more sensors 738 can be positioned at various interaction pointsalong the closure drive system to detect the closure forces applied tothe anvil 716 by the closure drive system. The one or more sensors 738may be sampled in real time during a clamping operation by the processorof the control circuit 710. The control circuit 710 receives real-timesample measurements to provide and analyze time-based information andassess, in real time, closure forces applied to the anvil 716.

In one aspect, a current sensor 736 can be employed to measure thecurrent drawn by each of the motors 704 a-704 e. The force required toadvance any of the movable mechanical elements such as the I-beam 714corresponds to the current drawn by one of the motors 704 a-704 e. Theforce is converted to a digital signal and provided to the controlcircuit 710. The control circuit 710 can be configured to simulate theresponse of the actual system of the instrument in the software of thecontroller. A displacement member can be actuated to move an I-beam 714in the end effector 702 at or near a target velocity. The roboticsurgical instrument 700 can include a feedback controller, which can beone of any feedback controllers, including, but not limited to a PID, astate feedback, a linear-quadratic (LQR), and/or an adaptive controller,for example. The robotic surgical instrument 700 can include a powersource to convert the signal from the feedback controller into aphysical input such as case voltage, PWM voltage, frequency modulatedvoltage, current, torque, and/or force, for example. Additional detailsare disclosed in U.S. patent application Ser. No. 15/636,829, titledCLOSED LOOP VELOCITY CONTROL TECHNIQUES FOR ROBOTIC SURGICAL INSTRUMENT,filed Jun. 29, 2017, which is herein incorporated by reference in itsentirety.

FIG. 18 illustrates a block diagram of a surgical instrument 750programmed to control the distal translation of a displacement member,in accordance with at least one aspect of this disclosure. In oneaspect, the surgical instrument 750 is programmed to control the distaltranslation of a displacement member such as the I-beam 764. Thesurgical instrument 750 comprises an end effector 752 that may comprisean anvil 766, an I-beam 764 (including a sharp cutting edge), and aremovable staple cartridge 768.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensor784. Because the I-beam 764 is coupled to a longitudinally movable drivemember, the position of the I-beam 764 can be determined by measuringthe position of the longitudinally movable drive member employing theposition sensor 784. Accordingly, in the following description, theposition, displacement, and/or translation of the I-beam 764 can beachieved by the position sensor 784 as described herein. A controlcircuit 760 may be programmed to control the translation of thedisplacement member, such as the I-beam 764. The control circuit 760, insome examples, may comprise one or more microcontrollers,microprocessors, or other suitable processors for executing instructionsthat cause the processor or processors to control the displacementmember, e.g., the I-beam 764, in the manner described. In one aspect, atimer/counter 781 provides an output signal, such as the elapsed time ora digital count, to the control circuit 760 to correlate the position ofthe I-beam 764 as determined by the position sensor 784 with the outputof the timer/counter 781 such that the control circuit 760 can determinethe position of the I-beam 764 at a specific time (t) relative to astarting position. The timer/counter 781 may be configured to measureelapsed time, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor 754 has been instructed to execute. The position sensor 784 may belocated in the end effector 752 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 752 andadapted to operate with the surgical instrument 750 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 752. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by a closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor of the control circuit760. The control circuit 760 receives real-time sample measurements toprovide and analyze time-based information and assess, in real time,closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

The control circuit 760 can be configured to simulate the response ofthe actual system of the instrument in the software of the controller. Adisplacement member can be actuated to move an I-beam 764 in the endeffector 752 at or near a target velocity. The surgical instrument 750can include a feedback controller, which can be one of any feedbackcontrollers, including, but not limited to a PID, a state feedback, LQR,and/or an adaptive controller, for example. The surgical instrument 750can include a power source to convert the signal from the feedbackcontroller into a physical input such as case voltage, PWM voltage,frequency modulated voltage, current, torque, and/or force, for example.

The actual drive system of the surgical instrument 750 is configured todrive the displacement member, cutting member, or I-beam 764, by abrushed DC motor with gearbox and mechanical links to an articulationand/or knife system. Another example is the electric motor 754 thatoperates the displacement member and the articulation driver, forexample, of an interchangeable shaft assembly. An outside influence isan unmeasured, unpredictable influence of things like tissue,surrounding bodies and friction on the physical system. Such outsideinfluence can be referred to as drag which acts in opposition to theelectric motor 754. The outside influence, such as drag, may cause theoperation of the physical system to deviate from a desired operation ofthe physical system.

Various example aspects are directed to a surgical instrument 750comprising an end effector 752 with motor-driven surgical stapling andcutting implements. For example, a motor 754 may drive a displacementmember distally and proximally along a longitudinal axis of the endeffector 752. The end effector 752 may comprise a pivotable anvil 766and, when configured for use, a staple cartridge 768 positioned oppositethe anvil 766. A clinician may grasp tissue between the anvil 766 andthe staple cartridge 768, as described herein. When ready to use theinstrument 750, the clinician may provide a firing signal, for exampleby depressing a trigger of the instrument 750. In response to the firingsignal, the motor 754 may drive the displacement member distally alongthe longitudinal axis of the end effector 752 from a proximal strokebegin position to a stroke end position distal of the stroke beginposition. As the displacement member translates distally, an I-beam 764with a cutting element positioned at a distal end, may cut the tissuebetween the staple cartridge 768 and the anvil 766.

In various examples, the surgical instrument 750 may comprise a controlcircuit 760 programmed to control the distal translation of thedisplacement member, such as the I-beam 764, for example, based on oneor more tissue conditions. The control circuit 760 may be programmed tosense tissue conditions, such as thickness, either directly orindirectly, as described herein. The control circuit 760 may beprogrammed to select a firing control program based on tissueconditions. A firing control program may describe the distal motion ofthe displacement member. Different firing control programs may beselected to better treat different tissue conditions. For example, whenthicker tissue is present, the control circuit 760 may be programmed totranslate the displacement member at a lower velocity and/or with lowerpower. When thinner tissue is present, the control circuit 760 may beprogrammed to translate the displacement member at a higher velocityand/or with higher power.

In some examples, the control circuit 760 may initially operate themotor 754 in an open loop configuration for a first open loop portion ofa stroke of the displacement member. Based on a response of theinstrument 750 during the open loop portion of the stroke, the controlcircuit 760 may select a firing control program. The response of theinstrument may include, a translation distance of the displacementmember during the open loop portion, a time elapsed during the open loopportion, energy provided to the motor 754 during the open loop portion,a sum of pulse widths of a motor drive signal, etc. After the open loopportion, the control circuit 760 may implement the selected firingcontrol program for a second portion of the displacement member stroke.For example, during the closed loop portion of the stroke, the controlcircuit 760 may modulate the motor 754 based on translation datadescribing a position of the displacement member in a closed loop mannerto translate the displacement member at a constant velocity. Additionaldetails are disclosed in U.S. patent application Ser. No. 15/720,852,titled SYSTEM AND METHODS FOR CONTROLLING A DISPLAY OF A SURGICALINSTRUMENT, filed Sep. 29, 2017, which is herein incorporated byreference in its entirety.

FIG. 19 is a schematic diagram of a surgical instrument 790 configuredto control various functions, in accordance with at least one aspect ofthis disclosure. In one aspect, the surgical instrument 790 isprogrammed to control distal translation of a displacement member suchas the I-beam 764. The surgical instrument 790 comprises an end effector792 that may comprise an anvil 766, an I-beam 764, and a removablestaple cartridge 768 which may be interchanged with an RF cartridge 796(shown in dashed line).

In one aspect, sensors 788 may be implemented as a limit switch,electromechanical device, solid-state switches, Hall-effect devices, MRdevices, GMR devices, magnetometers, among others. In otherimplementations, the sensors 638 may be solid-state switches thatoperate under the influence of light, such as optical sensors, IRsensors, ultraviolet sensors, among others. Still, the switches may besolid-state devices such as transistors (e.g., FET, junction FET,MOSFET, bipolar, and the like). In other implementations, the sensors788 may include electrical conductorless switches, ultrasonic switches,accelerometers, and inertial sensors, among others.

In one aspect, the position sensor 784 may be implemented as an absolutepositioning system comprising a magnetic rotary absolute positioningsystem implemented as an AS5055EQFT single-chip magnetic rotary positionsensor available from Austria Microsystems, AG. The position sensor 784may interface with the control circuit 760 to provide an absolutepositioning system. The position may include multiple Hall-effectelements located above a magnet and coupled to a CORDIC processor, alsoknown as the digit-by-digit method and Volder's algorithm, that isprovided to implement a simple and efficient algorithm to calculatehyperbolic and trigonometric functions that require only addition,subtraction, bitshift, and table lookup operations.

In one aspect, the I-beam 764 may be implemented as a knife membercomprising a knife body that operably supports a tissue cutting bladethereon and may further include anvil engagement tabs or features andchannel engagement features or a foot. In one aspect, the staplecartridge 768 may be implemented as a standard (mechanical) surgicalfastener cartridge. In one aspect, the RF cartridge 796 may beimplemented as an RF cartridge. These and other sensors arrangements aredescribed in commonly owned U.S. patent application Ser. No. 15/628,175,titled TECHNIQUES FOR ADAPTIVE CONTROL OF MOTOR VELOCITY OF A SURGICALSTAPLING AND CUTTING INSTRUMENT, filed Jun. 20, 2017, which is hereinincorporated by reference in its entirety.

The position, movement, displacement, and/or translation of a lineardisplacement member, such as the I-beam 764, can be measured by anabsolute positioning system, sensor arrangement, and position sensorrepresented as position sensor 784. Because the I-beam 764 is coupled tothe longitudinally movable drive member, the position of the I-beam 764can be determined by measuring the position of the longitudinallymovable drive member employing the position sensor 784. Accordingly, inthe following description, the position, displacement, and/ortranslation of the I-beam 764 can be achieved by the position sensor 784as described herein. A control circuit 760 may be programmed to controlthe translation of the displacement member, such as the I-beam 764, asdescribed herein. The control circuit 760, in some examples, maycomprise one or more microcontrollers, microprocessors, or othersuitable processors for executing instructions that cause the processoror processors to control the displacement member, e.g., the I-beam 764,in the manner described. In one aspect, a timer/counter 781 provides anoutput signal, such as the elapsed time or a digital count, to thecontrol circuit 760 to correlate the position of the I-beam 764 asdetermined by the position sensor 784 with the output of thetimer/counter 781 such that the control circuit 760 can determine theposition of the I-beam 764 at a specific time (t) relative to a startingposition. The timer/counter 781 may be configured to measure elapsedtime, count external events, or time external events.

The control circuit 760 may generate a motor set point signal 772. Themotor set point signal 772 may be provided to a motor controller 758.The motor controller 758 may comprise one or more circuits configured toprovide a motor drive signal 774 to the motor 754 to drive the motor 754as described herein. In some examples, the motor 754 may be a brushed DCelectric motor. For example, the velocity of the motor 754 may beproportional to the motor drive signal 774. In some examples, the motor754 may be a brushless DC electric motor and the motor drive signal 774may comprise a PWM signal provided to one or more stator windings of themotor 754. Also, in some examples, the motor controller 758 may beomitted, and the control circuit 760 may generate the motor drive signal774 directly.

The motor 754 may receive power from an energy source 762. The energysource 762 may be or include a battery, a super capacitor, or any othersuitable energy source. The motor 754 may be mechanically coupled to theI-beam 764 via a transmission 756. The transmission 756 may include oneor more gears or other linkage components to couple the motor 754 to theI-beam 764. A position sensor 784 may sense a position of the I-beam764. The position sensor 784 may be or include any type of sensor thatis capable of generating position data that indicate a position of theI-beam 764. In some examples, the position sensor 784 may include anencoder configured to provide a series of pulses to the control circuit760 as the I-beam 764 translates distally and proximally. The controlcircuit 760 may track the pulses to determine the position of the I-beam764. Other suitable position sensors may be used, including, forexample, a proximity sensor. Other types of position sensors may provideother signals indicating motion of the I-beam 764. Also, in someexamples, the position sensor 784 may be omitted. Where the motor 754 isa stepper motor, the control circuit 760 may track the position of theI-beam 764 by aggregating the number and direction of steps that themotor has been instructed to execute. The position sensor 784 may belocated in the end effector 792 or at any other portion of theinstrument.

The control circuit 760 may be in communication with one or more sensors788. The sensors 788 may be positioned on the end effector 792 andadapted to operate with the surgical instrument 790 to measure thevarious derived parameters such as gap distance versus time, tissuecompression versus time, and anvil strain versus time. The sensors 788may comprise a magnetic sensor, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as an eddycurrent sensor, a resistive sensor, a capacitive sensor, an opticalsensor, and/or any other suitable sensor for measuring one or moreparameters of the end effector 792. The sensors 788 may include one ormore sensors.

The one or more sensors 788 may comprise a strain gauge, such as amicro-strain gauge, configured to measure the magnitude of the strain inthe anvil 766 during a clamped condition. The strain gauge provides anelectrical signal whose amplitude varies with the magnitude of thestrain. The sensors 788 may comprise a pressure sensor configured todetect a pressure generated by the presence of compressed tissue betweenthe anvil 766 and the staple cartridge 768. The sensors 788 may beconfigured to detect impedance of a tissue section located between theanvil 766 and the staple cartridge 768 that is indicative of thethickness and/or fullness of tissue located therebetween.

The sensors 788 may be is configured to measure forces exerted on theanvil 766 by the closure drive system. For example, one or more sensors788 can be at an interaction point between a closure tube and the anvil766 to detect the closure forces applied by a closure tube to the anvil766. The forces exerted on the anvil 766 can be representative of thetissue compression experienced by the tissue section captured betweenthe anvil 766 and the staple cartridge 768. The one or more sensors 788can be positioned at various interaction points along the closure drivesystem to detect the closure forces applied to the anvil 766 by theclosure drive system. The one or more sensors 788 may be sampled in realtime during a clamping operation by a processor portion of the controlcircuit 760. The control circuit 760 receives real-time samplemeasurements to provide and analyze time-based information and assess,in real time, closure forces applied to the anvil 766.

A current sensor 786 can be employed to measure the current drawn by themotor 754. The force required to advance the I-beam 764 corresponds tothe current drawn by the motor 754. The force is converted to a digitalsignal and provided to the control circuit 760.

An RF energy source 794 is coupled to the end effector 792 and isapplied to the RF cartridge 796 when the RF cartridge 796 is loaded inthe end effector 792 in place of the staple cartridge 768. The controlcircuit 760 controls the delivery of the RF energy to the RF cartridge796.

Additional details are disclosed in U.S. patent application Ser. No.15/636,096, titled SURGICAL SYSTEM COUPLABLE WITH STAPLE CARTRIDGE ANDRADIO FREQUENCY CARTRIDGE, AND METHOD OF USING SAME, filed Jun. 28,2017, which is herein incorporated by reference in its entirety.

FIG. 20 illustrates a stroke length graph 20740 showing how a controlsystem can modify the stroke length of a closure tube assembly based onthe articulation angle θ. Such modifying of the stroke length includesshortening the stroke length to a compensated stroke length (e.g.,defined along the y-axis) as the articulation angle θ increases (e.g.,defined along the x-axis). The compensated stroke length defines alength of travel of the closure tube assembly in the distal direction toclose the jaws of an end effector, which is dependent upon thearticulation angle θ and prevents over-travel of the closure tubeassembly causing damage to the surgical device.

For example, as shown in the stroke length graph 20740, the strokelength of the closure tube assembly to close the jaws is approximately0.250 inches when the end effector is not articulated, and thecompensated stroke length is approximately 0.242 inches when thearticulation angle θ is approximately 60 degrees. Such measurements areprovided as examples only and can include any of a variety of angles andcorresponding stroke lengths and compensated stroke lengths withoutdeparting from the scope of this disclosure. Furthermore, therelationship between the articulation angles 6 and compensated strokelengths is non-linear and the rate at which the compensated strokelength shortens increases as the articulation angle increases. Forexample, the decrease in compensated stroke lengths between 45 degreesand 60 degrees articulation is greater than the decrease in compensatedstroke lengths between zero degrees and 15 degrees articulation.Although with this approach the control system is adjusting the strokelength based on the articulation angle θ to prevent damage to thesurgical device (e.g., jamming the distal end of the closure tubeassembly in a distal position), the distal closure tube is still allowedto advance during articulation, thereby potentially at least partlyclosing the jaws.

FIG. 21 illustrates a closure tube assembly positioning graph 20750showing one aspect in which a control system modifies a longitudinalposition of a closure tube assembly based on the articulation angle θ.Such modifying of the longitudinal position of the closure tube assemblyincludes proximally retracting the closure tube assembly by acompensation distance (e.g., defined along the y-axis) as the endeffector articulates and based on the articulation angle θ (e.g.,defined along the x-axis). The compensation distance that the closuretube assembly is proximally retracted prevents distal advancement of thedistal closure tube thereby maintaining the jaws in the open positionduring articulation. By proximally retracting the closure tube assemblyby the compensation distance during articulation, the closure tubeassembly can travel the stroke length starting form the proximallyretracted position to close the jaws upon activation of the closureassembly.

For example, as shown in the closure tube assembly positioning graph20750, the compensation distance when the end effector is notarticulated is zero and the compensation distance when the articulationangle θ is approximately 60 degrees is approximately 0.008 inches. Inthis example, the closure tube assembly is retracted by a 0.008 inchcompensation distance during articulation. As such, to close the jaws,the closure tube assembly can advance the stoke length starting fromthis retracted position. Such measurements are provided for examplepurposes only and can include any of a variety of angles andcorresponding compensation distances without departing from the scope ofthe disclosure. As shown in FIG. 21, the relationship between thearticulation angle and the compensation distance is non-linear and therate at which the compensation distance lengthens increases as thearticulation angle θ increases. For example, the increase incompensation distance between 45 degrees and 60 degrees is greater thanthe increase in compensation distance between zero degrees and 15degrees.

When clamping patient tissue, forces exerted through the clampingdevice, e.g., a linear stapler, and the tissue may reach an unacceptablyhigh level. For example, when a constant closure rate is employed, theforce may become high enough to cause excess trauma to the clampedtissue and may cause deformation in the clamping device such that anacceptable tissue gap is not maintained across the stapling path. FIG.22 is a graph illustrating the power applied to tissue duringcompression at a constant anvil closure rate (i.e.; without controlledtissue compression (CTC)) vs. the power applied to tissue duringcompression with a variable anvil closure rate (i.e.; with CTC). Theclosure rate may be adjusted to control tissue compression so that thepower imparted into the tissue remains constant over a portion of thecompression. The peak power imparted into the tissue according to FIG.22 is much lower when a variable anvil closure rate is utilized. Basedon the imparted power, the force exerted by the surgical device (or aparameter related to or proportional to the force) may be calculated. Inthis regard, the power may be limited such that the force exertedthrough the surgical device, e.g., through the jaws of a linear stapler,do not exceed a yield force or pressure that results in splaying of thejaws such that the tissue gap is not within an acceptable range alongthe entire stapling length when in the fully closed position. Forexample, the jaws should be parallel or close enough to parallel thatthe tissue gap remains within the acceptable or target range for allstaple positions along the entire length of the jaws. Further, thelimitation of the exerted power avoids, or at least minimizes, trauma ordamage to tissue.

In FIG. 22, the total energy exerted in the method without CTC is thesame as the total energy exerted in the method with CTC, i.e., the areasunder the power curves of FIG. 22 are the same or substantially thesame. The difference in the power profiles utilized is, however,substantial, as the peak power is much lower in the example with CTC ascompared to the example without CTC.

The limiting of power is achieved in the example with CTC by slowing theclosing rate, as illustrated by line 20760. It is noted that thecompression time B′ is longer than the closing time B. As illustrated inFIG. 22, a device and method that provides a constant closure rate(i.e.; without CTC) achieves the same 50 lb of compressive force at thesame 1 mm tissue gap as the device and method that provides a variableclosure rate (i.e.; with CTC). While the device and method that providefor a constant closure rate may achieve the compressive force at thedesired tissue gap in a shorter time period as compared with a deviceand method using a variable closure rate, this results in the spike inpower applied to the tissue, as shown in FIG. 22. In contrast, theexample aspect illustrated with CTC begins slowing the rate of closureto limit the amount of power applied to the tissue below a certainlevel. By limiting the power applied to the tissue, tissue trauma may beminimized with respect to the system and method that does not use CTC.

FIG. 22 and additional exemplifications are further described in U.S.Pat. No. 8,499,992, filed Jun. 1, 2012, titled DEVICE AND METHOD FORCONTROLLING COMPRESSION OF TISSUE, which issued Aug. 6, 2013, the entiredisclosure of which is incorporated by reference herein.

In some aspects, a control system can include a plurality of predefinedforce thresholds that assist the control system in determining aposition of an E-beam and/or articulation angle of a firing shaft andappropriately controlling at least one motor based on suchdetermination. For example, the force thresholds can change depending ona length of travel of the firing bar configured to translate the firingshaft, and such force thresholds can be compared to a measured torsionalforce of the one or more motors in communication with the controlsystem. Comparison of the measured torsional forces against the forcethresholds can provide a dependable way for the control system todetermine a location of the E-beam and/or articulation of the endeffector. This can allow the control system to appropriately control theone or more motors (e.g., reduce or stop torsional loads) to ensureproper firing of the firing assembly and articulation of the endeffector, as well as prevent against damage to the system, as will bedescribed in greater detail below.

FIG. 23 illustrates a force and displacement graph 20800 includingmeasured forces in section A that are related to measured displacementsin section B. Both section A and B have an x-axis defining time (e.g.,seconds). The y-axis of section B defines a travel displacement (e.g.,in millimeters) of a firing rod and the y-axis of section A defines aforce applied to the firing bar to thereby advance the firing shaft. Asshown in section A, travel of the firing bar within a first articulationrange 20902 (e.g., a first approximately 12 mm of travel) causes the endeffector to articulate. For example, at the 12 mm displacement positionthe end effector is fully articulated to the right and is mechanicallyunable to articulate further. As a result of being at full articulationthe torsional force on the motor will increase and the control systemcan sense an articulation force peak 20802 that exceeds a predefinedarticulation threshold 20804, as shown in section A. The control systemcan include more than one predefined articulation threshold 20804 forsensing more than one max articulation direction (e.g., leftarticulation and right articulation). After the control system detectsan articulation force peak 20802 that exceeds the predeterminedarticulation threshold 20804, the control system can reduce or stopactuation of the motor thereby protecting at least the motor fromdamage.

After the firing bar advances past the articulation range 20902, ashifting mechanism within the surgical stapler can cause further distaltravel of the firing bar to cause distal travel of the firing shaft. Forexample, as shown in section B, travel between approximately 12 mm and70 mm of travel displacement can cause the E-beam to advance along afiring stroke 20904 and cut tissue captured between the jaws, however,other lengths of travel are within the scope of this disclosure. In thisexample, a maximum firing stroke position 20906 of the E-beam occurs at70 mm travel. At this point, the E-beam or knife abuts a distal end ofthe cartridge or jaw thereby increasing torsional forces on the motorand causing a knife travel force peak 20806, as shown in section A, tobe sensed by the control system. As shown in section A, the controlsystem can include a motor threshold 20808 and an end of knife travelthreshold 20810 that branches off from the motor threshold 20808 anddecreases (e.g., non-linearly) as the E-beam approaches the maximumfiring stroke position 20906.

The control system can be configured to monitor the sensed motortorsional force during at least the last part of distal travel 20907(e.g., last 10 percent of the firing stroke 904) of the E-beam beforereaching the maximum firing stroke position 20906. While monitoringalong such last part of distal travel 20907, the control system cancause the motor to reduce torsional forces to thereby reduce the load onthe E-beam. This can protect damage to the surgical stapler, includingthe E-beam, by reducing loads on the E-beam as the E-beam approaches themaximum firing stroke position 20906 thereby reducing impact of theE-beam against the distal end of the cartridge or jaw. As mentionedabove, such impact can cause a knife travel force peak 20806, which canexceed the knife travel threshold 20810 but not the motor threshold20808 thereby not damaging the motor. As such, the control system canstop actuation of the motor after the knife travel force peak 20806exceeds the knife travel threshold 20810 and before the knife travelforce peak 20806 exceeds the motor threshold 20808 thereby protectingthe motor from damage. Furthermore, the increasing reduction in theknife travel threshold 20810 prevents the control system frompreliminarily thinking that the E-beam has reached the maximum firingstroke position 20906.

After the control system has detected a knife travel force peak 20806exceeding the knife travel threshold 20810, the control system canconfirm a position of the E-beam (e.g., at 70 mm displacement and/or atend of firing stroke 20904) and can retract the firing bar based on suchknown displacement position to reset the E-beam in a most proximalposition 20908 (e.g., 0 mm displacement). At the most proximal position20908, a knife retraction force peak 20812 that exceeds a predefinedknife retraction threshold 20814, as shown in section A, can be sensedby the control system. At this point, the control system canrecalibrate, if needed, and associate the position of the E-beam asbeing in a home position where subsequent advancement of the firing rodin the distal direction (e.g., approximately 12 mm in length) will causethe shifter to disengage the E-beam from the firing bar. Oncedisengaged, firing bar travel within the articulation range 20902 willagain cause articulation of the end effector.

As such, the control system can sense torsional forces on the motorcontrolling travel of the firing bar and compare such sensed torsionalforces against a plurality of thresholds to determine a position of theE-beam or angle of articulation of the end effector and therebyappropriately control the motor to prevent damage to the motor, as wellas confirm positioning of the firing bar and/or E-beam.

As described supra, tissue contact or pressure sensors determine whenthe jaw members initially come into contact with the tissue “T”. Thisenables a surgeon to determine the initial thickness of the tissue “T”and/or the thickness of the tissue “T” prior to clamping. In any of thesurgical instrument aspects described above, as seen in FIG. 24, contactof the jaw members with tissue “T” closes a sensing circuit “SC” that isotherwise open, by establishing contacting with a pair of opposed plates“P1, P2” provided on the jaw members. The contact sensors may alsoinclude sensitive force transducers that determine the amount of forcebeing applied to the sensor, which may be assumed to be the same amountof force being applied to the tissue “T”. Such force being applied tothe tissue, may then be translated into an amount of tissue compression.The force sensors measure the amount of compression a tissue is underand provide a surgeon with information about the force applied to thetissue “T”. Excessive tissue compression may have a negative impact onthe tissue “T” being operated on. For example, excessive compression oftissue “T” may result in tissue necrosis and, in certain procedures,staple line failure. Information regarding the pressure being applied totissue “T” enables a surgeon to better determine that excessive pressureis not being applied to tissue “T”.

Any of the contact sensors disclosed herein may include, and are notlimited to, electrical contacts placed on an inner surface of a jawwhich, when in contact with tissue, close a sensing circuit that isotherwise open. The contact sensors may also include sensitive forcetransducers that detect when the tissue being clamped first resistscompression. Force transducers may include, and are not limited to,piezoelectric elements, piezoresistive elements, metal film orsemiconductor strain gauges, inductive pressure sensors, capacitivepressure sensors, and potentiometric pressure transducers that usebourbon tubes, capsules or bellows to drive a wiper arm on a resistiveelement.

In an aspect, any one of the aforementioned surgical instruments mayinclude one or more piezoelectric elements to detect a change inpressure occurring on the jaw members. Piezoelectric elements arebi-directional transducers which convert stress into an electricalpotential. Elements may consist of metallized quartz or ceramics. Inoperation, when stress is applied to the crystals there is a change inthe charge distribution of the material resulting in a generation ofvoltage across the material. Piezoelectric elements may be used toindicate when any one or both of the jaw members makes contact with thetissue “T” and the amount of pressure exerted on the tissue “T” aftercontact is established.

In an aspect, any one of the aforementioned surgical instruments mayinclude or be provided with one or more metallic strain gauges placedwithin or upon a portion of the body thereof. Metallic strain gaugesoperate on the principle that the resistance of the material dependsupon length, width and thickness. Accordingly, when the material of themetallic strain gauge undergoes strain the resistance of the materialchanges. Thus, a resistor made of this material incorporated into acircuit will convert strain to a change in an electrical signal.Desirably, the strain gauge may be placed on the surgical instrumentssuch that pressure applied to the tissue effects the strain gauge.

Alternatively, in another aspect, one or more semiconductor straingauges may be used in a similar manner as the metallic strain gaugedescribed above, although the mode of transduction differs. Inoperation, when a crystal lattice structure of the semiconductor straingauge is deformed, as a result of an applied stress, the resistance ofthe material changes. This phenomenon is referred to as thepiezoresistive effect.

In yet another aspect, any one of the aforementioned surgicalinstruments may include or be provided with one or more inductivepressure sensors to transduce pressure or force into motion of inductiveelements relative to each other. This motion of the inductive elementsrelative to one another alters the overall inductance or inductivecoupling. Capacitive pressure transducers similarly transduce pressureor force into motion of capacitive elements relative to each otheraltering the overall capacitance.

In still another aspect, any one of the aforementioned surgicalinstruments may include or be provided with one or more capacitivepressure transducers to transduce pressure or force into motion ofcapacitive elements relative to each other altering an overallcapacitance.

In an aspect, any one of the aforementioned surgical instruments mayinclude or be provided with one or more mechanical pressure transducersto transduce pressure or force into motion. In use, a motion of amechanical element is used to deflect a pointer or dial on a gauge. Thismovement of the pointer or dial may be representative of the pressure orforce applied to the tissue “T”. Examples of mechanical elements includeand are not limited to bourbon tubes, capsules or bellows. By way ofexample, mechanical elements may be coupled with other measuring and/orsensing elements, such as a potentiometer pressure transducer. In thisexample the mechanical element is coupled with a wiper on the variableresistor. In use, pressure or force may be transduced into mechanicalmotion which deflects the wiper on the potentiometer thus changing theresistance to reflect the applied pressure or force.

The combination of the above aspects, in particular the combination ofthe gap and tissue contact sensors, provides the surgeon with feedbackinformation and/or real-time information regarding the condition of theoperative site and/or target tissue “T”. For example, informationregarding the initial thickness of the tissue “T” may guide the surgeonin selecting an appropriate staple size, information regarding theclamped thickness of the tissue “T” may let the surgeon know if theselected staple will form properly, information relating to the initialthickness and clamped thickness of the tissue “T” may be used todetermine the amount of compression or strain on the tissue “T”, andinformation relating to the strain on the tissue “T” may be used thisstrain to avoid compressing tissue to excessive strain values and/orstapling into tissue that has undergone excessive strain.

Additionally, force sensors may be used to provide the surgeon with theamount of pressure applied to the tissue. The surgeon may use thisinformation to avoid applying excessive pressure on the tissue “T” orstapling into tissue “T” which has experienced excessive strain.

FIG. 24 and additional exemplifications are further described in U.S.Pat. No. 8,181,839, filed Jun. 27, 2011, titled SURGICAL INSTRUMENTEMPLOYING SENSORS, which issued May 5, 2012, the entire disclosure ofwhich is incorporated by reference herein.

Certain aspects are shown and described to provide an understanding ofthe structure, function, manufacture, and use of the disclosed devicesand methods. Features shown or described in one example may be combinedwith features of other examples and modifications and variations arewithin the scope of this disclosure.

The terms “proximal” and “distal” are relative to a clinicianmanipulating the handle of the surgical instrument where “proximal”refers to the portion closer to the clinician and “distal” refers to theportion located further from the clinician. For expediency, spatialterms “vertical,” “horizontal,” “up,” and “down” used with respect tothe drawings are not intended to be limiting and/or absolute, becausesurgical instruments can used in many orientations and positions.

Example devices and methods are provided for performing laparoscopic andminimally invasive surgical procedures. Such devices and methods,however, can be used in other surgical procedures and applicationsincluding open surgical procedures, for example. The surgicalinstruments can be inserted into a through a natural orifice or throughan incision or puncture hole formed in tissue. The working portions orend effector portions of the instruments can be inserted directly intothe body or through an access device that has a working channel throughwhich the end effector and elongated shaft of the surgical instrumentcan be advanced.

FIGS. 25 to 28 depict a motor-driven surgical instrument 150010 forcutting and fastening that may or may not be reused. In the illustratedexamples, the surgical instrument 150010 includes a housing 150012 thatcomprises a handle assembly 150014 that is configured to be grasped,manipulated, and actuated by the clinician. The housing 150012 isconfigured for operable attachment to an interchangeable shaft assembly150200 that has an end effector 150300 operably coupled thereto that isconfigured to perform one or more surgical tasks or procedures. Inaccordance with the present disclosure, various forms of interchangeableshaft assemblies may be effectively employed in connection withrobotically controlled surgical systems. The term “housing” mayencompass a housing or similar portion of a robotic system that housesor otherwise operably supports at least one drive system configured togenerate and apply at least one control motion that could be used toactuate interchangeable shaft assemblies. The term “frame” may refer toa portion of a handheld surgical instrument. The term “frame” also mayrepresent a portion of a robotically controlled surgical instrumentand/or a portion of the robotic system that may be used to operablycontrol a surgical instrument. Interchangeable shaft assemblies may beemployed with various robotic systems, instruments, components, andmethods disclosed in U.S. Pat. No. 9,072,535, titled SURGICAL STAPLINGINSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, which isherein incorporated by reference in its entirety.

FIG. 25 is a perspective view of a surgical instrument 150010 that hasan interchangeable shaft assembly 150200 operably coupled thereto, inaccordance with at least one aspect of this disclosure. The housing150012 includes an end effector 150300 that comprises a surgical cuttingand fastening device configured to operably support a surgical staplecartridge 150304 therein. The housing 150012 may be configured for usein connection with interchangeable shaft assemblies that include endeffectors that are adapted to support different sizes and types ofstaple cartridges, have different shaft lengths, sizes, and types. Thehousing 150012 may be employed with a variety of interchangeable shaftassemblies, including assemblies configured to apply other motions andforms of energy such as, radio frequency (RF) energy, ultrasonic energy,and/or motion to end effector arrangements adapted for use in connectionwith various surgical applications and procedures. The end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

The handle assembly 150014 may comprise a pair of interconnectablehandle housing segments 150016, 150018 interconnected by screws, snapfeatures, adhesive, etc. The handle housing segments 150016, 150018cooperate to form a pistol grip portion 150019 that can be gripped andmanipulated by the clinician. The handle assembly 150014 operablysupports a plurality of drive systems configured to generate and applycontrol motions to corresponding portions of the interchangeable shaftassembly that is operably attached thereto. A display may be providedbelow a cover 150045.

FIG. 26 is an exploded assembly view of a portion of the surgicalinstrument 150010 of FIG. 25, in accordance with at least one aspect ofthis disclosure. The handle assembly 150014 may include a frame 150020that operably supports a plurality of drive systems. The frame 150020can operably support a “first” or closure drive system 150030, which canapply closing and opening motions to the interchangeable shaft assembly150200. The closure drive system 150030 may include an actuator such asa closure trigger 150032 pivotally supported by the frame 150020. Theclosure trigger 150032 is pivotally coupled to the handle assembly150014 by a pivot pin 150033 to enable the closure trigger 150032 to bemanipulated by a clinician. When the clinician grips the pistol gripportion 150019 of the handle assembly 150014, the closure trigger 150032can pivot from a starting or “unactuated” position to an “actuated”position and more particularly to a fully compressed or fully actuatedposition.

The handle assembly 150014 and the frame 150020 may operably support afiring drive system 150080 configured to apply firing motions tocorresponding portions of the interchangeable shaft assembly attachedthereto. The firing drive system 150080 may employ an electric motor150082 located in the pistol grip portion 150019 of the handle assembly150014. The electric motor 150082 may be a DC brushed motor having amaximum rotational speed of approximately 25,000 RPM, for example. Inother arrangements, the motor may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The electric motor 150082 may be powered by a powersource 150090 that may comprise a removable power pack 150092. Theremovable power pack 150092 may comprise a proximal housing portion150094 configured to attach to a distal housing portion 150096. Theproximal housing portion 150094 and the distal housing portion 150096are configured to operably support a plurality of batteries 150098therein. Batteries 150098 may each comprise, for example, a Lithium Ion(LI) or other suitable battery. The distal housing portion 150096 isconfigured for removable operable attachment to a control circuit board150100, which is operably coupled to the electric motor 150082. Severalbatteries 150098 connected in series may power the surgical instrument150010. The power source 150090 may be replaceable and/or rechargeable.A display 150043, which is located below the cover 150045, iselectrically coupled to the control circuit board 150100. The cover150045 may be removed to expose the display 150043.

The electric motor 150082 can include a rotatable shaft (not shown) thatoperably interfaces with a gear reducer assembly 150084 mounted inmeshing engagement with a with a set, or rack, of drive teeth 150122 ona longitudinally movable drive member 150120. The longitudinally movabledrive member 150120 has a rack of drive teeth 150122 formed thereon formeshing engagement with a corresponding drive gear 150086 of the gearreducer assembly 150084.

In use, a voltage polarity provided by the power source 150090 canoperate the electric motor 150082 in a clockwise direction wherein thevoltage polarity applied to the electric motor by the battery can bereversed in order to operate the electric motor 150082 in acounter-clockwise direction. When the electric motor 150082 is rotatedin one direction, the longitudinally movable drive member 150120 will beaxially driven in the distal direction “DD.” When the electric motor150082 is driven in the opposite rotary direction, the longitudinallymovable drive member 150120 will be axially driven in a proximaldirection “PD.” The handle assembly 150014 can include a switch that canbe configured to reverse the polarity applied to the electric motor150082 by the power source 150090. The handle assembly 150014 mayinclude a sensor configured to detect the position of the longitudinallymovable drive member 150120 and/or the direction in which thelongitudinally movable drive member 150120 is being moved.

Actuation of the electric motor 150082 can be controlled by a firingtrigger 150130 that is pivotally supported on the handle assembly150014. The firing trigger 150130 may be pivoted between an unactuatedposition and an actuated position.

Turning back to FIG. 25, the interchangeable shaft assembly 150200includes an end effector 150300 comprising an elongated channel 150302configured to operably support a surgical staple cartridge 150304therein. The end effector 150300 may include an anvil 150306 that ispivotally supported relative to the elongated channel 150302. Theinterchangeable shaft assembly 150200 may include an articulation joint150270. Construction and operation of the end effector 150300 and thearticulation joint 150270 are set forth in U.S. Patent ApplicationPublication No. 2014/0263541, titled ARTICULATABLE SURGICAL INSTRUMENTCOMPRISING AN ARTICULATION LOCK, which is herein incorporated byreference in its entirety. The interchangeable shaft assembly 150200 mayinclude a proximal housing or nozzle 150201 comprised of nozzle portions150202, 150203. The interchangeable shaft assembly 150200 may include aclosure tube 150260 extending along a shaft axis SA that can be utilizedto close and/or open the anvil 150306 of the end effector 150300.

Turning back to FIG. 25, the closure tube 150260 is translated distally(direction “DD”) to close the anvil 150306, for example, in response tothe actuation of the closure trigger 150032 in the manner described inthe aforementioned reference U.S. Patent Application Publication No.2014/0263541. The anvil 150306 is opened by proximally translating theclosure tube 150260. In the anvil-open position, the closure tube 150260is moved to its proximal position.

FIG. 27 is another exploded assembly view of portions of theinterchangeable shaft assembly 150200, in accordance with at least oneaspect of this disclosure. The interchangeable shaft assembly 150200 mayinclude a firing member 150220 supported for axial travel within thespine 150210. The firing member 150220 includes an intermediate firingshaft 150222 configured to attach to a distal cutting portion or knifebar 150280. The firing member 150220 may be referred to as a “secondshaft” or a “second shaft assembly”. The intermediate firing shaft150222 may include a longitudinal slot 150223 in a distal end configuredto receive a tab 150284 on the proximal end 150282 of the knife bar150280. The longitudinal slot 150223 and the proximal end 150282 may beconfigured to permit relative movement there between and can comprise aslip joint 150286. The slip joint 150286 can permit the intermediatefiring shaft 150222 of the firing member 150220 to articulate the endeffector 150300 about the articulation joint 150270 without moving, orat least substantially moving, the knife bar 150280. Once the endeffector 150300 has been suitably oriented, the intermediate firingshaft 150222 can be advanced distally until a proximal sidewall of thelongitudinal slot 150223 contacts the tab 150284 to advance the knifebar 150280 and fire the staple cartridge positioned within the channel150302. The spine 150210 has an elongated opening or window 150213therein to facilitate assembly and insertion of the intermediate firingshaft 150222 into the spine 150210. Once the intermediate firing shaft150222 has been inserted therein, a top frame segment 150215 may beengaged with the shaft frame 150212 to enclose the intermediate firingshaft 150222 and knife bar 150280 therein. Operation of the firingmember 150220 may be found in U.S. Patent Application Publication No.2014/0263541. A spine 150210 can be configured to slidably support afiring member 150220 and the closure tube 150260 that extends around thespine 150210. The spine 150210 may slidably support an articulationdriver 150230.

The interchangeable shaft assembly 150200 can include a clutch assembly150400 configured to selectively and releasably couple the articulationdriver 150230 to the firing member 150220. The clutch assembly 150400includes a lock collar, or lock sleeve 150402, positioned around thefiring member 150220 wherein the lock sleeve 150402 can be rotatedbetween an engaged position in which the lock sleeve 150402 couples thearticulation driver 150230 to the firing member 150220 and a disengagedposition in which the articulation driver 150230 is not operably coupledto the firing member 150220. When the lock sleeve 150402 is in theengaged position, distal movement of the firing member 150220 can movethe articulation driver 150230 distally and, correspondingly, proximalmovement of the firing member 150220 can move the articulation driver150230 proximally. When the lock sleeve 150402 is in the disengagedposition, movement of the firing member 150220 is not transmitted to thearticulation driver 150230 and, as a result, the firing member 150220can move independently of the articulation driver 150230. The nozzle150201 may be employed to operably engage and disengage the articulationdrive system with the firing drive system in the various mannersdescribed in U.S. Patent Application Publication No. 2014/0263541.

The interchangeable shaft assembly 150200 can comprise a slip ringassembly 150600 which can be configured to conduct electrical power toand/or from the end effector 150300 and/or communicate signals to and/orfrom the end effector 150300, for example. The slip ring assembly 150600can comprise a proximal connector flange 150604 and a distal connectorflange 150601 positioned within a slot defined in the nozzle portions150202, 150203. The proximal connector flange 150604 can comprise afirst face and the distal connector flange 150601 can comprise a secondface positioned adjacent to and movable relative to the first face. Thedistal connector flange 150601 can rotate relative to the proximalconnector flange 150604 about the shaft axis SA-SA (FIG. 25). Theproximal connector flange 150604 can comprise a plurality of concentric,or at least substantially concentric, conductors 150602 defined in thefirst face thereof. A connector 150607 can be mounted on the proximalside of the distal connector flange 150601 and may have a plurality ofcontacts wherein each contact corresponds to and is in electricalcontact with one of the conductors 150602. Such an arrangement permitsrelative rotation between the proximal connector flange 150604 and thedistal connector flange 150601 while maintaining electrical contactthere between. The proximal connector flange 150604 can include anelectrical connector 150606 that can place the conductors 150602 insignal communication with a shaft circuit board, for example. In atleast one instance, a wiring harness comprising a plurality ofconductors can extend between the electrical connector 150606 and theshaft circuit board. The electrical connector 150606 may extendproximally through a connector opening defined in the chassis mountingflange. U.S. Patent Application Publication No. 2014/0263551, titledSTAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, is incorporated hereinby reference in its entirety. U.S. Patent Application Publication No.2014/0263552, titled STAPLE CARTRIDGE TISSUE THICKNESS SENSOR SYSTEM, isincorporated by reference in its entirety. Further details regardingslip ring assembly 150600 may be found in U.S. Patent ApplicationPublication No. 2014/0263541.

The interchangeable shaft assembly 150200 can include a proximal portionfixably mounted to the handle assembly 150014 and a distal portion thatis rotatable about a longitudinal axis. The rotatable distal shaftportion can be rotated relative to the proximal portion about the slipring assembly 150600. The distal connector flange 150601 of the slipring assembly 150600 can be positioned within the rotatable distal shaftportion.

FIG. 28 is an exploded view of one aspect of an end effector 150300 ofthe surgical instrument 150010 of FIG. 25, in accordance with at leastone aspect of this disclosure. The end effector 150300 may include theanvil 150306 and the surgical staple cartridge 150304. The anvil 150306may be coupled to an elongated channel 150302. Apertures 150199 can bedefined in the elongated channel 150302 to receive pins 150152 extendingfrom the anvil 150306 to allow the anvil 150306 to pivot from an openposition to a closed position relative to the elongated channel 150302and surgical staple cartridge 150304. A firing bar 150172 is configuredto longitudinally translate into the end effector 150300. The firing bar150172 may be constructed from one solid section, or may include alaminate material comprising a stack of steel plates. The firing bar150172 comprises an I-beam 150178 and a cutting edge 150182 at a distalend thereof. A distally projecting end of the firing bar 150172 can beattached to the I-beam 150178 to assist in spacing the anvil 150306 froma surgical staple cartridge 150304 positioned in the elongated channel150302 when the anvil 150306 is in a closed position. The I-beam 150178may include a sharpened cutting edge 150182 to sever tissue as theI-beam 150178 is advanced distally by the firing bar 150172. Inoperation, the I-beam 150178 may, or fire, the surgical staple cartridge150304. The surgical staple cartridge 150304 can include a moldedcartridge body 150194 that holds a plurality of staples 150191 restingupon staple drivers 150192 within respective upwardly open staplecavities 150195. A wedge sled 150190 is driven distally by the I-beam150178, sliding upon a cartridge tray 150196 of the surgical staplecartridge 150304. The wedge sled 150190 upwardly cams the staple drivers150192 to force out the staples 150191 into deforming contact with theanvil 150306 while the cutting edge 150182 of the I-beam 150178 seversclamped tissue.

The I-beam 150178 can include upper pins 150180 that engage the anvil150306 during firing. The I-beam 150178 may include middle pins 150184and a bottom foot 150186 to engage portions of the cartridge body150194, cartridge tray 150196, and elongated channel 150302. When asurgical staple cartridge 150304 is positioned within the elongatedchannel 150302, a slot 150193 defined in the cartridge body 150194 canbe aligned with a longitudinal slot 150197 defined in the cartridge tray150196 and a slot 150189 defined in the elongated channel 150302. Inuse, the I-beam 150178 can slide through the aligned longitudinal slots150193, 150197, and 150189 wherein, as indicated in FIG. 28, the bottomfoot 150186 of the I-beam 150178 can engage a groove running along thebottom surface of elongated channel 150302 along the length of slot150189, the middle pins 150184 can engage the top surfaces of cartridgetray 150196 along the length of longitudinal slot 150197, and the upperpins 150180 can engage the anvil 150306. The I-beam 150178 can space, orlimit the relative movement between, the anvil 150306 and the surgicalstaple cartridge 150304 as the firing bar 150172 is advanced distally tofire the staples from the surgical staple cartridge 150304 and/or incisethe tissue captured between the anvil 150306 and the surgical staplecartridge 150304. The firing bar 150172 and the I-beam 150178 can beretracted proximally allowing the anvil 150306 to be opened to releasethe two stapled and severed tissue portions.

FIGS. 29A and 29B is a block diagram of a control circuit 150700 of thesurgical instrument 150010 of FIG. 25 spanning two drawing sheets, inaccordance with at least one aspect of this disclosure. Referringprimarily to FIGS. 29A and 29B, a handle assembly 150702 may include amotor 150714 which can be controlled by a motor driver 150715 and can beemployed by the firing system of the surgical instrument 150010. Invarious forms, the motor 150714 may be a DC brushed driving motor havinga maximum rotational speed of approximately 25,000 RPM. In otherarrangements, the motor 150714 may include a brushless motor, a cordlessmotor, a synchronous motor, a stepper motor, or any other suitableelectric motor. The motor driver 150715 may comprise an H-Bridge drivercomprising field-effect transistors (FETs) 150719, for example. Themotor 150714 can be powered by the power assembly 150706 releasablymounted to the handle assembly 150200 for supplying control power to thesurgical instrument 150010. The power assembly 150706 may comprise abattery which may include a number of battery cells connected in seriesthat can be used as the power source to power the surgical instrument150010. In certain circumstances, the battery cells of the powerassembly 150706 may be replaceable and/or rechargeable. In at least oneexample, the battery cells can be Lithium-Ion batteries which can beseparably couplable to the power assembly 150706.

The shaft assembly 150704 may include a shaft assembly controller 150722which can communicate with a safety controller and power managementcontroller 150716 through an interface while the shaft assembly 150704and the power assembly 150706 are coupled to the handle assembly 150702.For example, the interface may comprise a first interface portion 150725which may include one or more electric connectors for couplingengagement with corresponding shaft assembly electric connectors and asecond interface portion 150727 which may include one or more electricconnectors for coupling engagement with corresponding power assemblyelectric connectors to permit electrical communication between the shaftassembly controller 150722 and the power management controller 150716while the shaft assembly 150704 and the power assembly 150706 arecoupled to the handle assembly 150702. One or more communication signalscan be transmitted through the interface to communicate one or more ofthe power requirements of the attached interchangeable shaft assembly150704 to the power management controller 150716. In response, the powermanagement controller may modulate the power output of the battery ofthe power assembly 150706, as described below in greater detail, inaccordance with the power requirements of the attached shaft assembly150704. The connectors may comprise switches which can be activatedafter mechanical coupling engagement of the handle assembly 150702 tothe shaft assembly 150704 and/or to the power assembly 150706 to allowelectrical communication between the shaft assembly controller 150722and the power management controller 150716.

The interface can facilitate transmission of the one or morecommunication signals between the power management controller 150716 andthe shaft assembly controller 150722 by routing such communicationsignals through a main controller 150717 residing in the handle assembly150702, for example. In other circumstances, the interface canfacilitate a direct line of communication between the power managementcontroller 150716 and the shaft assembly controller 150722 through thehandle assembly 150702 while the shaft assembly 150704 and the powerassembly 150706 are coupled to the handle assembly 150702.

The main controller 150717 may be any single core or multicore processorsuch as those known under the trade name ARM Cortex by TexasInstruments. In one aspect, the main controller 150717 may be anLM4F230H5QR ARM Cortex-M4F Processor Core, available from TexasInstruments, for example, comprising on-chip memory of 256 KBsingle-cycle flash memory, or other non-volatile memory, up to 40 MHz, aprefetch buffer to improve performance above 40 MHz, a 32 KBsingle-cycle serial random access memory (SRAM), internal read-onlymemory (ROM) loaded with StellarisWare® software, 2 KB electricallyerasable programmable read-only memory (EEPROM), one or more pulse widthmodulation (PWM) modules, one or more quadrature encoder inputs (QEI)analog, one or more 12-bit Analog-to-Digital Converters (ADC) with 12analog input channels, details of which are available for the productdatasheet.

The safety controller may be a safety controller platform comprising twocontroller-based families such as TMS570 and RM4x known under the tradename Hercules ARM Cortex R4, also by Texas Instruments. The safetycontroller may be configured specifically for IEC 61508 and ISO 26262safety critical applications, among others, to provide advancedintegrated safety features while delivering scalable performance,connectivity, and memory options.

The power assembly 150706 may include a power management circuit whichmay comprise the power management controller 150716, a power modulator150738, and a current sense circuit 150736. The power management circuitcan be configured to modulate power output of the battery based on thepower requirements of the shaft assembly 150704 while the shaft assembly150704 and the power assembly 150706 are coupled to the handle assembly150702. The power management controller 150716 can be programmed tocontrol the power modulator 150738 of the power output of the powerassembly 150706 and the current sense circuit 150736 can be employed tomonitor power output of the power assembly 150706 to provide feedback tothe power management controller 150716 about the power output of thebattery so that the power management controller 150716 may adjust thepower output of the power assembly 150706 to maintain a desired output.The power management controller 150716 and/or the shaft assemblycontroller 150722 each may comprise one or more processors and/or memoryunits which may store a number of software modules.

The surgical instrument 150010 (FIGS. 25 to 28) may comprise an outputdevice 150742 which may include devices for providing a sensory feedbackto a user. Such devices may comprise, for example, visual feedbackdevices (e.g., an LCD display screen, LED indicators), audio feedbackdevices (e.g., a speaker, a buzzer) or tactile feedback devices (e.g.,haptic actuators). In certain circumstances, the output device 150742may comprise a display 150743 which may be included in the handleassembly 150702. The shaft assembly controller 150722 and/or the powermanagement controller 150716 can provide feedback to a user of thesurgical instrument 150010 through the output device 150742. Theinterface can be configured to connect the shaft assembly controller150722 and/or the power management controller 150716 to the outputdevice 150742. The output device 150742 can instead be integrated withthe power assembly 150706. In such circumstances, communication betweenthe output device 150742 and the shaft assembly controller 150722 may beaccomplished through the interface while the shaft assembly 150704 iscoupled to the handle assembly 150702.

The control circuit 150700 comprises circuit segments configured tocontrol operations of the powered surgical instrument 150010. A safetycontroller segment (Segment 1) comprises a safety controller and themain controller 150717 segment (Segment 2). The safety controller and/orthe main controller 150717 are configured to interact with one or moreadditional circuit segments such as an acceleration segment, a displaysegment, a shaft segment, an encoder segment, a motor segment, and apower segment. Each of the circuit segments may be coupled to the safetycontroller and/or the main controller 150717. The main controller 150717is also coupled to a flash memory. The main controller 150717 alsocomprises a serial communication interface. The main controller 150717comprises a plurality of inputs coupled to, for example, one or morecircuit segments, a battery, and/or a plurality of switches. Thesegmented circuit may be implemented by any suitable circuit, such as,for example, a printed circuit board assembly (PCBA) within the poweredsurgical instrument 150010. It should be understood that the termprocessor as used herein includes any microprocessor, processors,controller, controllers, or other basic computing device thatincorporates the functions of a computer's central processing unit (CPU)on an integrated circuit or at most a few integrated circuits. The maincontroller 150717 is a multipurpose, programmable device that acceptsdigital data as input, processes it according to instructions stored inits memory, and provides results as output. It is an example ofsequential digital logic, as it has internal memory. The control circuit150700 can be configured to implement one or more of the processesdescribed herein.

The acceleration segment (Segment 3) comprises an accelerometer. Theaccelerometer is configured to detect movement or acceleration of thepowered surgical instrument 150010. Input from the accelerometer may beused to transition to and from a sleep mode, identify an orientation ofthe powered surgical instrument, and/or identify when the surgicalinstrument has been dropped. In some examples, the acceleration segmentis coupled to the safety controller and/or the main controller 150717.

The display segment (Segment 4) comprises a display connector coupled tothe main controller 150717. The display connector couples the maincontroller 150717 to a display through one or more integrated circuitdrivers of the display. The integrated circuit drivers of the displaymay be integrated with the display and/or may be located separately fromthe display. The display may comprise any suitable display, such as, forexample, an organic light-emitting diode (OLED) display, aliquid-crystal display (LCD), and/or any other suitable display. In someexamples, the display segment is coupled to the safety controller.

The shaft segment (Segment 5) comprises controls for an interchangeableshaft assembly 150200 (FIGS. 25 and 27) coupled to the surgicalinstrument 150010 (FIGS. 25 to 28) and/or one or more controls for anend effector 150300 coupled to the interchangeable shaft assembly150200. The shaft segment comprises a shaft connector configured tocouple the main controller 150717 to a shaft PCBA. The shaft PCBAcomprises a low-power microcontroller with a ferroelectric random accessmemory (FRAM), an articulation switch, a shaft release Hall effectswitch, and a shaft PCBA EEPROM. The shaft PCBA EEPROM comprises one ormore parameters, routines, and/or programs specific to theinterchangeable shaft assembly 150200 and/or the shaft PCBA. The shaftPCBA may be coupled to the interchangeable shaft assembly 150200 and/orintegral with the surgical instrument 150010. In some examples, theshaft segment comprises a second shaft EEPROM. The second shaft EEPROMcomprises a plurality of algorithms, routines, parameters, and/or otherdata corresponding to one or more shaft assemblies 150200 and/or endeffectors 150300 that may be interfaced with the powered surgicalinstrument 150010.

The position encoder segment (Segment 6) comprises one or more magneticangle rotary position encoders. The one or more magnetic angle rotaryposition encoders are configured to identify the rotational position ofthe motor 150714, an interchangeable shaft assembly 150200 (FIGS. 25 and27), and/or an end effector 150300 of the surgical instrument 150010(FIGS. 25 to 28). In some examples, the magnetic angle rotary positionencoders may be coupled to the safety controller and/or the maincontroller 150717.

The motor circuit segment (Segment 7) comprises a motor 150714configured to control movements of the powered surgical instrument150010 (FIGS. 25 to 28). The motor 150714 is coupled to the mainmicrocontroller processor 150717 by an H-bridge driver comprising one ormore H-bridge field-effect transistors (FETs) and a motor controller.The H-bridge driver is also coupled to the safety controller. A motorcurrent sensor is coupled in series with the motor to measure thecurrent draw of the motor. The motor current sensor is in signalcommunication with the main controller 150717 and/or the safetycontroller. In some examples, the motor 150714 is coupled to a motorelectromagnetic interference (EMI) filter.

The motor controller controls a first motor flag and a second motor flagto indicate the status and position of the motor 150714 to the maincontroller 150717. The main controller 150717 provides a pulse-widthmodulation (PWM) high signal, a PWM low signal, a direction signal, asynchronize signal, and a motor reset signal to the motor controllerthrough a buffer. The power segment is configured to provide a segmentvoltage to each of the circuit segments.

The power segment (Segment 8) comprises a battery coupled to the safetycontroller, the main controller 150717, and additional circuit segments.The battery is coupled to the segmented circuit by a battery connectorand a current sensor. The current sensor is configured to measure thetotal current draw of the segmented circuit. In some examples, one ormore voltage converters are configured to provide predetermined voltagevalues to one or more circuit segments. For example, in some examples,the segmented circuit may comprise 3.3V voltage converters and/or 5Vvoltage converters. A boost converter is configured to provide a boostvoltage up to a predetermined amount, such as, for example, up to 13V.The boost converter is configured to provide additional voltage and/orcurrent during power intensive operations and prevent brownout orlow-power conditions.

A plurality of switches are coupled to the safety controller and/or themain controller 150717. The switches may be configured to controloperations of the surgical instrument 150010 (FIGS. 25 to 28), of thesegmented circuit, and/or indicate a status of the surgical instrument150010. A bail-out door switch and Hall effect switch for bailout areconfigured to indicate the status of a bail-out door. A plurality ofarticulation switches, such as, for example, a left side articulationleft switch, a left side articulation right switch, a left sidearticulation center switch, a right side articulation left switch, aright side articulation right switch, and a right side articulationcenter switch are configured to control articulation of aninterchangeable shaft assembly 150200 (FIGS. 25 and 27) and/or the endeffector 150300 (FIGS. 25 and 28). A left side reverse switch and aright side reverse switch are coupled to the main controller 150717. Theleft side switches comprising the left side articulation left switch,the left side articulation right switch, the left side articulationcenter switch, and the left side reverse switch are coupled to the maincontroller 150717 by a left flex connector. The right side switchescomprising the right side articulation left switch, the right sidearticulation right switch, the right side articulation center switch,and the right side reverse switch are coupled to the main controller150717 by a right flex connector. A firing switch, a clamp releaseswitch, and a shaft engaged switch are coupled to the main controller150717.

Any suitable mechanical, electromechanical, or solid state switches maybe employed to implement the plurality of switches, in any combination.For example, the switches may be limit switches operated by the motionof components associated with the surgical instrument 150010 (FIGS. 25to 28) or the presence of an object. Such switches may be employed tocontrol various functions associated with the surgical instrument150010. A limit switch is an electromechanical device that consists ofan actuator mechanically linked to a set of contacts. When an objectcomes into contact with the actuator, the device operates the contactsto make or break an electrical connection. Limit switches are used in avariety of applications and environments because of their ruggedness,ease of installation, and reliability of operation. They can determinethe presence or absence, passing, positioning, and end of travel of anobject. In other implementations, the switches may be solid stateswitches that operate under the influence of a magnetic field such asHall-effect devices, magneto-resistive (MR) devices, giantmagneto-resistive (GMR) devices, magnetometers, among others. In otherimplementations, the switches may be solid state switches that operateunder the influence of light, such as optical sensors, infrared sensors,ultraviolet sensors, among others. Still, the switches may be solidstate devices such as transistors (e.g., FET, Junction-FET, metal-oxidesemiconductor-FET (MOSFET), bipolar, and the like). Other switches mayinclude wireless switches, ultrasonic switches, accelerometers, inertialsensors, among others.

FIG. 30 is another block diagram of the control circuit 150700 of thesurgical instrument of FIG. 25 illustrating interfaces between thehandle assembly 150702 and the power assembly 150706 and between thehandle assembly 150702 and the interchangeable shaft assembly 150704, inaccordance with at least one aspect of this disclosure. The handleassembly 150702 may comprise a main controller 150717, a shaft assemblyconnector 150726 and a power assembly connector 150730. The powerassembly 150706 may include a power assembly connector 150732, a powermanagement circuit 150734 that may comprise the power managementcontroller 150716, a power modulator 150738, and a current sense circuit150736. The shaft assembly connectors 150730, 150732 form an interface150727. The power management circuit 150734 can be configured tomodulate power output of the battery 150707 based on the powerrequirements of the interchangeable shaft assembly 150704 while theinterchangeable shaft assembly 150704 and the power assembly 150706 arecoupled to the handle assembly 150702. The power management controller150716 can be programmed to control the power modulator 150738 of thepower output of the power assembly 150706 and the current sense circuit150736 can be employed to monitor power output of the power assembly150706 to provide feedback to the power management controller 150716about the power output of the battery 150707 so that the powermanagement controller 150716 may adjust the power output of the powerassembly 150706 to maintain a desired output. The shaft assembly 150704comprises a shaft processor 150720 coupled to a non-volatile memory150721 and shaft assembly connector 150728 to electrically couple theshaft assembly 150704 to the handle assembly 150702. The shaft assemblyconnectors 150726, 150728 form interface 150725. The main controller150717, the shaft processor 150720, and/or the power managementcontroller 150716 can be configured to implement one or more of theprocesses described herein.

The surgical instrument 150010 (FIGS. 25 to 28) may comprise an outputdevice 150742 to a sensory feedback to a user. Such devices may comprisevisual feedback devices (e.g., an LCD display screen, LED indicators),audio feedback devices (e.g., a speaker, a buzzer), or tactile feedbackdevices (e.g., haptic actuators). In certain circumstances, the outputdevice 150742 may comprise a display 150743 that may be included in thehandle assembly 150702. The shaft assembly controller 150722 and/or thepower management controller 150716 can provide feedback to a user of thesurgical instrument 150010 through the output device 150742. Theinterface 150727 can be configured to connect the shaft assemblycontroller 150722 and/or the power management controller 150716 to theoutput device 150742. The output device 150742 can be integrated withthe power assembly 150706. Communication between the output device150742 and the shaft assembly controller 150722 may be accomplishedthrough the interface 150725 while the interchangeable shaft assembly150704 is coupled to the handle assembly 150702. Having described acontrol circuit 150700 (FIGS. 29A and 29B and 6) for controlling theoperation of the surgical instrument 150010 (FIGS. 25 to 28), thedisclosure now turns to various configurations of the surgicalinstrument 150010 (FIGS. 25 to 28) and control circuit 150700.

Referring to FIG. 31, a surgical stapler 151000 may include a handlecomponent 151002, a shaft component 151004, and an end-effectorcomponent 151006. The surgical stapler 151000 is similarly constructedand equipped as the motor-driven surgical cutting and fasteninginstrument 150010 described in connection with FIG. 25. Accordingly, forconciseness and clarity the details of operation and construction willnot be repeated here. The end-effector 151006 may be used to compress,cut, or staple tissue. Referring now to FIG. 32, an end-effector 151030may be positioned by a physician to surround tissue 151032 prior tocompression, cutting, or stapling. As shown in FIG. 32, no compressionmay be applied to the tissue while preparing to use the end-effector.Referring now to FIG. 33, by engaging the handle (e.g., handle 151002)of the surgical stapler, the physician may use the end-effector 151030to compress the tissue 151032. In one aspect, the tissue 151032 may becompressed to its maximum threshold, as shown in FIG. 33.

Referring to FIG. 34, various forces may be applied to the tissue 151032by the end-effector 151030. For example, vertical forces F1 and F2 maybe applied by the anvil 151034 and the channel frame 151036 of theend-effector 151030 as tissue 151032 is compressed between the two.Referring now to FIG. 35, various diagonal and/or lateral forces alsomay be applied to the tissue 151032 when compressed by the end-effector151030. For example, force F3 may be applied. For the purposes ofoperating a medical device such as surgical stapler 151000, it may bedesirable to sense or calculate the various forms of compression beingapplied to the tissue by the end-effector. For example, knowledge ofvertical or lateral compression may allow the end-effector to moreprecisely or accurately apply a staple operation or may inform theoperator of the surgical stapler such that the surgical stapler can beused more properly or safely.

The compression through tissue 151032 may be determined from animpedance of tissue 151032. At various levels of compression, theimpedance Z of tissue 151032 may increase or decrease. By applying avoltage V and a current I to the tissue 151032, the impedance Z of thetissue 151032 may be determined at various levels of compression. Forexample, impedance Z may be calculated by dividing the applied voltage Vby the current I.

Referring now to FIG. 36, in one aspect, an RF electrode 151038 may bepositioned on the end-effector 151030 (e.g., on a staple cartridge,knife, or channel frame of the end-effector 151030). Further, anelectrical contact 151040 may be positioned on the anvil 151034 of theend-effector 151030. In one aspect, the electrical contact may bepositioned on the channel frame of the end-effector. As the tissue151032 is compressed between the anvil 151034 and, for example, thechannel frame 151036 of the end-effector 151030, an impedance Z of thetissue 151032 changes. The vertical tissue compression 151042 caused bythe end-effector 151030 may be measured as a function of the impedance Zof the tissue 151032.

Referring now to FIG. 37, in one aspect, an electrical contact 151044may be positioned on an opposite end of the anvil 151034 of theend-effector 151030 as the RF electrode 151038 is positioned. As thetissue 151032 is compressed between the anvil 151034 and, for example,the channel frame 151036 of the end-effector 151030, an impedance Z ofthe tissue 151032 changes. The lateral tissue compression 151046 causedby the end-effector 151030 may be measured as a function of theimpedance Z of the tissue 151032.

Referring now to FIG. 38, in one aspect, electrical contact 151050 maybe positioned on the anvil 151034 and electrical contact 151052 may bepositioned on an opposite end of the end-effector 151030 at channelframe 151036. RF electrode 151048 may be positioned laterally to thecentral to the end-effector 151030. As the tissue 151032 is compressedbetween the anvil 151034 and, for example, the channel frame 151036 ofthe end-effector 151030, an impedance Z of the tissue 151032 changes.The lateral compression or angular compressions 151054 and 151056 oneither side of the RF electrode 151048 may be caused by the end-effector151030 and may be measured as a function of different impedances Z ofthe tissue 151032, based on the relative positioning of the RF electrode151048 and electrical contacts 151050 and 151052.

Referring now to FIG. 39, a frequency generator 151222 may receive poweror current from a power source 151221 and may supply one or more RFsignals to one or more RF electrodes 151224. As discussed above, the oneor more RF electrodes may be positioned at various locations orcomponents on an end-effector or surgical stapler, such as a staplecartridge or channel frame. One or more electrical contacts, such aselectrical contacts 151226 or 151228 may be positioned on a channelframe or an anvil of an end-effector. Further, one or more filters, suchas filters 151230 or 151232 may be communicatively coupled to theelectrical contacts 151226 or 151228. The filters 151230 and 151232 mayfilter one or more RF signals supplied by the frequency generator 151222before joining a single return path 151234. A voltage V and a current Iassociated with the one or more RF signals may be used to calculate animpedance Z associated with a tissue that may be compressed and/orcommunicatively coupled between the one or more RF electrodes 151224 andthe electrical contacts 151226 or 151228.

Referring still to FIG. 39, various components of the tissue compressionsensor system described herein may be located in a handle 151236 of asurgical stapler. For example, as shown in circuit diagram 151220 a,frequency generator 151222 may be located in the handle 151236 andreceives power from power source 151221. Also, current I1 and current I2may be measured on a return path corresponding to electrical contacts151228 and 151226. Using a voltage V applied between the supply andreturn paths, impedances Z1 and Z2 may be calculated. Z1 may correspondto an impedance of a tissue compressed and/or communicatively coupledbetween one or more of RF electrodes 151224 and electrical contact151228. Further, Z2 may correspond to an impedance of a tissuecompressed and/or communicatively coupled between one or more of RFelectrodes 151224 and electrical contact 151226. Applying the formulasZ1=V/I1 and Z2=V/I2, impedances Z1 and Z2 corresponding to differentcompression levels of a tissue compressed by an end-effector may becalculated.

Referring now to FIG. 40, one or more aspects of the present disclosureare described in circuit diagram 151250. In an implementation, a powersource at a handle 151252 of a surgical stapler may provide power to afrequency generator 151254. The frequency generator 151254 may generateone or more RF signals. The one or more RF signals may be multiplexed oroverlaid at a multiplexer 151256, which may be in a shaft 151258 of thesurgical stapler. In this way, two or more RF signals may be overlaid(or, e.g., nested or modulated together) and transmitted to theend-effector. The one or more RF signals may energize one or more RFelectrodes 151260 at an end-effector 151262 (e.g., positioned in astaple cartridge) of the surgical stapler. A tissue (not shown) may becompressed and/or communicatively coupled between the one or more of RFelectrodes 151260 and one or more electrical contacts. For example, thetissue may be compressed and/or communicatively coupled between the oneor more RF electrodes 151260 and the electrical contact 151264positioned in a channel frame of the end-effector 151262 or theelectrical contact 151266 positioned in an anvil of the end-effector151262. A filter 151268 may be communicatively coupled to the electricalcontact 151264 and a filter 151270 may be communicatively coupled to theelectrical contact 151266.

A voltage V and a current I associated with the one or more RF signalsmay be used to calculate an impedance Z associated with a tissue thatmay be compressed between the staple cartridge (and communicativelycoupled to one or more RF electrodes 151260) and the channel frame oranvil (and communicatively coupled to one or more of electrical contacts151264 or 151266).

In one aspect, various components of the tissue compression sensorsystem described herein may be located in a shaft 151258 of the surgicalstapler. For example, as shown in circuit diagram 151250 (and inaddition to the frequency generator 151254), an impedance calculator151272, a controller 151274, a non-volatile memory 151276, and acommunication channel 151278 may be located in the shaft 151258. In oneexample, the frequency generator 151254, impedance calculator 151272,controller 151274, non-volatile memory 151276, and communication channel151278 may be positioned on a circuit board in the shaft 151258.

The two or more RF signals may be returned on a common path via theelectrical contacts. Further, the two or more RF signals may be filteredprior to the joining of the RF signals on the common path todifferentiate separate tissue impedances represented by the two or moreRF signals. Current I1 and current I2 may be measured on a return pathcorresponding to electrical contacts 151264 and 151266. Using a voltageV applied between the supply and return paths, impedances Z1 and Z2 maybe calculated. Z1 may correspond to an impedance of a tissue compressedand/or communicatively coupled between one or more of RF electrodes151260 and electrical contact 151264. Further, Z2 may correspond to animpedance of the tissue compressed and/or communicatively coupledbetween one or more of RF electrodes 151260 and electrical contact151266. Applying the formulas Z1=V/I1 and Z2=V/I2, impedances Z1 and Z2corresponding to different compressions of a tissue compressed by anend-effector 151262 may be calculated. In example, the impedances Z1 andZ2 may be calculated by the impedance calculator 151272. The impedancesZ1 and Z2 may be used to calculate various compression levels of thetissue.

Referring now to FIG. 41, a frequency graph 151290 is shown. Thefrequency graph 151290 shows a frequency modulation to nest two RFsignals. The two RF signals may be nested before reaching RF electrodesat an end-effector as described above. For example, an RF signal withFrequency 1 and an RF signal with Frequency 2 may be nested together.Referring now to FIG. 42, the resulting nested RF signal is shown infrequency graph 151300. The compound signal shown in frequency graph151300 includes the two RF signals of frequency graph 151290 compounded.Referring now to FIG. 43, a frequency graph 151400 is shown. Frequencygraph 151400 shows the RF signals with Frequencies 1 and 2 after beingfiltered (by, e.g., filters 151268 and 151270). The resulting RF signalscan be used to make separate impedance calculations or measurements on areturn path, as described above.

In one aspect, filters 151268 and 151270 may be High Q filters such thatthe filter range may be narrow (e.g., Q=10). Q may be defined by theCenter frequency (Wo)/Bandwidth (BW) where Q=Wo/BW. In one example,Frequency 1 may be 150 kHz and Frequency 2 may be 300 kHz. A viableimpedance measurement range may be 100 kHz-20 MHz. In various examples,other sophisticated techniques, such as correlation, quadraturedetection, etc., may be used to separate the RF signals.

Using one or more of the techniques and features described herein, asingle energized electrode on a staple cartridge or an isolated knife ofan end-effector may be used to make multiple tissue compressionmeasurements simultaneously. If two or more RF signals are overlaid ormultiplexed (or nested or modulated), they may be transmitted down asingle power side of the end-effector and may return on either thechannel frame or the anvil of the end-effector. If a filter were builtinto the anvil and channel contacts before they join a common returnpath, the tissue impedance represented by both paths could bedifferentiated. This may provide a measure of vertical tissue vs lateraltissue compression. This approach also may provide proximal and distaltissue compression depending on placement of the filters and location ofthe metallic return paths. A frequency generator and signal processormay be located on one or more chips on a circuit board or a sub board(which may already exist in a surgical stapler).

In one aspect, the present disclosure provides an instrument 150010(described in connection with FIGS. 25-30) configured with varioussensing systems. Accordingly, for conciseness and clarity the details ofoperation and construction will not be repeated here. In one aspect, thesensing system includes a viscoelasticity/rate of change sensing systemto monitor knife acceleration, rate of change of impedance, and rate ofchange of tissue contact. In one example, the rate of change of knifeacceleration can be used as a measure of for tissue type. In anotherexample, the rate of change of impedance can be measures with a pulsesensor ad can be employed as a measure for compressibility. Finally, therate of change of tissue contact can be measured with a sensor based onknife firing rate to measure tissue flow.

The rate of change of a sensed parameter or stated otherwise, how muchtime is necessary for a tissue parameter to reach an asymptotic steadystate value, is a separate measurement in itself and may be morevaluable than the sensed parameter it was derived from. To enhancemeasurement of tissue parameters such as waiting a predetermined amountof time before making a measurement, the present disclosure provides anovel technique for employing the derivate of the measure such as therate of change of the tissue parameter.

The derivative technique or rate of change measure becomes most usefulwith the understanding that there is no single measurement that can beemployed alone to dramatically improve staple formation. It is thecombination of multiple measurements that make the measurements valid.In the case of tissue gap it is helpful to know how much of the jaw iscovered with tissue to make the gap measure relevant. Rate of changemeasures of impedance may be combined with strain measurements in theanvil to relate force and compression applied to the tissue graspedbetween the jaw members of the end effector such as the anvil and thestaple cartridge. The rate of change measure can be employed by theendosurgical device to determine the tissue type and not merely thetissue compression. Although stomach and lung tissue sometimes havesimilar thicknesses, and even similar compressive properties when thelung tissue is calcified, an instrument may be able to distinguish thesetissue types by employing a combination of measurements such as gap,compression, force applied, tissue contact area, and rate of change ofcompression or rate of change of gap. If any of these measurements wereused alone, it may be difficult for the endosurgical device todistinguish one tissue type form another. Rate of change of compressionalso may be helpful to enable the device to determine if the tissue is“normal” or if some abnormality exists. Measuring not only how much timehas passed but the variation of the sensor signals and determining thederivative of the signal would provide another measurement to enable theendosurgical device to measure the signal. Rate of change informationalso may be employed in determining when a steady state has beenachieved to signal the next step in a process. For example, afterclamping the tissue between the jaw members of the end effector such asthe anvil and the staple cartridge, when tissue compression reaches asteady state (e.g., about 15 seconds), an indicator or trigger to startfiring the device can be enabled.

Also provided herein are methods, devices, and systems for timedependent evaluation of sensor data to determine stability, creep, andviscoelastic characteristics of tissue during surgical instrumentoperation. A surgical instrument, such as the stapler illustrated inFIG. 25, can include a variety of sensors for measuring operationalparameters, such as jaw gap size or distance, firing current, tissuecompression, the amount of the jaw that is covered by tissue, anvilstrain, and trigger force, to name a few. These sensed measurements areimportant for automatic control of the surgical instrument and forproviding feedback to the clinician.

The examples shown in connection with FIGS. 30-49 may be employed tomeasure the various derived parameters such as gap distance versus time,tissue compression versus time, and anvil strain versus time. Motorcurrent may be monitored employing a current sensor in series with thebattery 2308.

Turning now to FIG. 44, a motor-driven surgical cutting and fasteninginstrument 151310 is depicted that may or may not be reused. Themotor-driven surgical cutting and fastening instrument 151310 issimilarly constructed and equipped as the motor-driven surgical cuttingand fastening instrument 150010 described in connection with FIGS.25-30. In the example illustrated in FIG. 44, the instrument 151310includes a housing 151312 that comprises a handle assembly 151314 thatis configured to be grasped, manipulated and actuated by the clinician.The housing 151312 is configured for operable attachment to aninterchangeable shaft assembly 151500 that has a surgical end effector151600 operably coupled thereto that is configured to perform one ormore surgical tasks or procedures. Since the motor-driven surgicalcutting and fastening instrument 151310 is similarly constructed andequipped as the motor-driven surgical cutting and fastening instrument150010 described in connection with FIGS. 25-30, for conciseness andclarity the details of operation and construction will not be repeatedhere.

The housing 151312 depicted in FIG. 44 is shown in connection with aninterchangeable shaft assembly 151500 that includes an end effector151600 that comprises a surgical cutting and fastening device that isconfigured to operably support a surgical staple cartridge 151304therein. The housing 151312 may be configured for use in connection withinterchangeable shaft assemblies that include end effectors that areadapted to support different sizes and types of staple cartridges, havedifferent shaft lengths, sizes, and types, etc. In addition, the housing151312 also may be effectively employed with a variety of otherinterchangeable shaft assemblies including those assemblies that areconfigured to apply other motions and forms of energy such as, forexample, radio frequency (RF) energy, ultrasonic energy and/or motion toend effector arrangements adapted for use in connection with varioussurgical applications and procedures. Furthermore, the end effectors,shaft assemblies, handles, surgical instruments, and/or surgicalinstrument systems can utilize any suitable fastener, or fasteners, tofasten tissue. For instance, a fastener cartridge comprising a pluralityof fasteners removably stored therein can be removably inserted intoand/or attached to the end effector of a shaft assembly.

FIG. 44 illustrates the surgical instrument 151310 with aninterchangeable shaft assembly 151500 operably coupled thereto. In theillustrated arrangement, the handle housing forms a pistol grip portion151319 that can be gripped and manipulated by the clinician. The handleassembly 151314 operably supports a plurality of drive systems thereinthat are configured to generate and apply various control motions tocorresponding portions of the interchangeable shaft assembly that isoperably attached thereto. Trigger 151332 is operably associated withthe pistol grip for controlling various of these control motions.

With continued reference to FIG. 44, the interchangeable shaft assembly151500 includes a surgical end effector 151600 that comprises anelongated channel 151302 that is configured to operably support a staplecartridge 151304 therein. The end effector 151600 may further include ananvil 151306 that is pivotally supported relative to the elongatedchannel 151302.

The inventors have discovered that derived parameters can be even moreuseful for controlling a surgical instrument, such as the instrumentillustrated in FIG. 44, than the sensed parameter(s) upon which thederived parameter is based. Non-limiting examples of derived parametersinclude the rate of change of a sensed parameter (e.g., jaw gapdistance) and how much time elapses before a tissue parameter reaches anasymptotic steady state value (e.g., 15 seconds). Derived parameters,such as rate of change, are particularly useful because theydramatically improve measurement accuracy and also provide informationnot otherwise evident directly from sensed parameters. For example,impedance (i.e., tissue compression) rate of change can be combined withstrain in the anvil to relate compression and force, which enables themicrocontroller to determine the tissue type and not merely the amountof tissue compression. This example is illustrative only, and anyderived parameters can be combined with one or more sensed parameters toprovide more accurate information about tissue types (e.g., stomach vs.lung), tissue health (calcified vs. normal), and operational status ofthe surgical device (e.g., clamping complete). Different tissues haveunique viscoelastic properties and unique rates of change, making theseand other parameters discussed herein useful indicia for monitoring andautomatically adjusting a surgical procedure.

FIG. 46 is an illustrative graph showing gap distance over time, wherethe gap is the space between the jaws being occupied by clamped tissue.The vertical (y) axis is distance and the horizontal (x) axis is time.Specifically, referring to FIGS. 44 and 45, the gap distance 151340 isthe distance between the anvil 151306 and the elongated channel 151302of the end effector. In the open jaw position, at time zero, the gap151340 between the anvil 151306 and the elongated member is at itsmaximum distance. The width of the gap 151340 decreases as the anvil151306 closes, such as during tissue clamping. The gap distance rate ofchange can vary because tissue has non-uniform resiliency. For example,certain tissue types may initially show rapid compression, resulting ina faster rate of change. However, as tissue is continually compressed,the viscoelastic properties of the tissue can cause the rate of changeto decrease until the tissue cannot be compressed further, at whichpoint the gap distance will remain substantially constant. The gapdecreases over time as the tissue is squeezed between the anvil 151306and the staple cartridge 151304 of the end effector 151340. The one ormore sensors described in connection with FIGS. 31 to 43 such as, forexample, a magnetic field sensor, a strain gauge, a pressure sensor, aforce sensor, an inductive sensor such as, for example, an eddy currentsensor, a resistive sensor, a capacitive sensor, an optical sensor,and/or any other suitable sensor, may be adapted and configured tomeasure the gap distance “d” between the anvil 151306 and the staplecartridge 151304 over time “t” as represented graphically in FIG. 46.The rate of change of the gap distance “d” over time “t” is the Slope ofthe curve shown in FIG. 46, where Slope=Δd/Δt.

FIG. 47 is an illustrative graph showing firing current of the endeffector jaws. The vertical (y) axis is current and the horizontal (x)axis is time. As discussed herein, the surgical instrument and/or themicrocontroller, as shown and described in connection with FIG. 25,thereof can include a current sensor that detects the current utilizedduring various operations, such as clamping, cutting, and/or staplingtissue. For example, when tissue resistance increases, the instrument'selectric motor can require more current to clamp, cut, and/or staple thetissue. Similarly, if resistance is lower, the electric motor canrequire less current to clamp, cut, and/or staple the tissue. As aresult, firing current can be used as an approximation of tissueresistance. The sensed current can be used alone or more preferably inconjunction with other measurements to provide feedback about the targettissue. Referring still to FIG. 47, during some operations, such asstapling, firing current initially is high at time zero but decreasesover time. During other device operations, current may increase overtime if the motor draws more current to overcome increasing mechanicalload. In addition, the rate of change of firing current is can be usedas an indicator that the tissue is transitioning from one state toanother state. Accordingly, firing current and, in particular, the rateof change of firing current can be used to monitor device operation. Thefiring current decreases over time as the knife cuts through the tissue.The rate of change of firing current can vary if the tissue being cutprovides more or less resistance due to tissue properties or sharpnessof the knife 151305 (FIG. 45). As the cutting conditions vary, the workbeing done by the motor varies and hence will vary the firing currentover time. A current sensor may be may be employed to measure the firingcurrent over time while the knife 151305 is firing as representedgraphically in FIG. 47. For example, the motor current may be monitoredemploying a current sensor. The current sensors may be adapted andconfigured to measure the motor firing current “i” over time “t” asrepresented graphically in FIG. 47. The rate of change of the firingcurrent “i” over time “t” is the Slope of the curve shown in FIG. 47,where Slope=Δi/Δt.

FIG. 48 is an illustrative graph of impedance over time. The vertical(y) axis is impedance and the horizontal (x) axis is time. At time zero,impedance is low but increases over time as tissue pressure increasesunder manipulation (e.g., clamping and stapling). The rate of changevaries over time as because as the tissue between the anvil 151306 andthe staple cartridge 151304 of the end effector 151340 is severed by theknife or is sealed using RF energy between electrodes located betweenthe anvil 151306 and the staple cartridge 151304 of the end effector151340. For example, as the tissue is cut the electrical impedanceincreases and reaches infinity when the tissue is completely severed bythe knife. Also, if the end effector 151340 includes electrodes coupledto an RF energy source, the electrical impedance of the tissue increasesas energy is delivered through the tissue between the anvil 151306 andthe staple cartridge 151304 of the end effector 151340. The electricalimpedance increase as the energy through the tissue dries out the tissueby vaporizing moistures in the tissue. Eventually, when a suitableamount of energy is delivered to the tissue, the impedance increases toa very high value or infinity when the tissue is severed. In addition,as illustrated in FIG. 48, different tissues can have unique compressionproperties, such as rate of compression, that distinguish tissues. Thetissue impedance can be measured by driving a sub-therapeutic RF currentthrough the tissue grasped between the first and second jaw members9014, 9016. One or more electrodes can be positioned on either or boththe anvil 151306 and the staple cartridge 151304. The tissuecompression/impedance of the tissue between the anvil 151306 and thestaple cartridge 151304 can be measured over time as representedgraphically in FIG. 48. The sensors described in connection with FIGS.31 to 43 such as, for example, a magnetic field sensor, a strain gauge,a pressure sensor, a force sensor, an inductive sensor such as, forexample, an eddy current sensor, a resistive sensor, a capacitivesensor, an optical sensor, and/or any other suitable sensor, may beadapted and configured to measure tissue compression/impedance. Thesensors may be adapted and configured to measure tissue impedance “Z”over time “t” as represented graphically in FIG. 48.

FIG. 49 is an illustrative graph of anvil 151306 (FIGS. 44, 45) strainover time. The vertical (y) axis is strain and the horizontal (x) axisis time. During stapling, for example, anvil 151306 strain initially ishigh but decreases as the tissue reaches a steady state and exerts lesspressure on the anvil 151306. The rate of change of anvil 151306 straincan be measured by a pressure sensor or strain gauge positioned oneither or both the anvil 151306 and the staple cartridge 151304 (FIGS.44, 45) to measure the pressure or strain applied to the tissue graspedbetween the anvil 151306 and the staple cartridge 151304. The anvil151306 strain can be measured over time as represented graphically inFIG. 49. The rate of change of strain “S” over time “t” is the Slope ofthe curve shown in FIG. 49, where Slope=ΔS/Δt.

FIG. 50 is an illustrative graph of trigger force over time. Thevertical (y) axis is trigger force and the horizontal (x) axis is time.In certain examples, trigger force is progressive, to provide theclinician tactile feedback. Thus, at time zero, trigger 151320 (FIG. 44)pressure may be at its lowest and trigger pressure may increase untilcompletion of an operation (e.g., clamping, cutting, or stapling). Therate of change trigger force can be measured by a pressure sensor orstrain gauge positioned on the trigger 151302 of the handle 151319 ofthe instrument 151310 (FIG. 44) to measure the force required to drivethe knife 151305 (FIG. 45) through the tissue grasped between the anvil151306 and the staple cartridge 151304. The trigger 151332 force can bemeasured over time as represented graphically in FIG. 50. The rate ofchange of strain trigger force “F” over time “t” is the Slope of thecurve shown in FIG. 50, where Slope=ΔF/Δt.

For example, stomach and lung tissue can be differentiated even thoughthese tissue can have similar thicknesses, and can have similarcompressive properties if the lung tissue is calcified. Stomach and lungtissues can be distinguished by analyzing jaw gap distance, tissuecompression, force applied, tissue contact area, compression rate ofchange, and jaw gap rate of change. For example, FIG. 51 shows a graphof tissue pressure “P” versus tissue displacement for various tissues.The vertical (y) axis is tissue pressure and the horizontal (x) axis istissue displacement. When tissue pressure reaches a predeterminedthreshold, such as 50-100 pounds per square inch (psi), the amount oftissue displacement as well as the rate of tissue displacement beforereaching the threshold can be used to differentiate tissues. Forinstance, blood vessel tissue reaches the predetermined pressurethreshold with less tissue displacement and with a faster rate of changethan colon, lung, or stomach tissue. In addition, the rate of change(tissue pressure over displacement) for blood vessel tissue is nearlyasymptotic at a threshold of 50-100 psi, whereas the rate of change forcolon, lung, and stomach is not asymptotic at a threshold of 50-100 psi.As will be appreciated, any pressure threshold can be used such as, forexample, between 1 and 1000 psi, more preferably between 10 and 500 psi,and more preferably still between 50 and 100 psi. In addition, multiplethresholds or progressive thresholds can be used to provide furtherresolution of tissue types that have similar viscoelastic properties.

Compression rate of change also can enable the microcontroller todetermine if the tissue is “normal” or if some abnormality exists, suchas calcification. For example, referring to FIG. 52, compression ofcalcified lung tissue follows a different curve than compression ofnormal lung tissue. Tissue displacement and rate of change of tissuedisplacement therefore can be used to diagnose and/or differentiatecalcified lung tissue from normal lung tissue.

In addition, certain sensed measurements may benefit from additionalsensory input. For example, in the case of jaw gap, knowing how much ofthe jaw is covered with tissue can make the gap measurement more usefuland accurate. If a small portion of the jaw is covered in tissue, tissuecompression may appear to be less than if the entire jaw is covered intissue. Thus, the amount of jaw coverage can be taken into account bythe microcontroller when analyzing tissue compression and other sensedparameters.

In certain circumstances, elapsed time also can be an importantparameter. Measuring how much time has passed, together with sensedparameters, and derivative parameters (e.g., rate of change) providesfurther useful information. For example, if jaw gap rate of changeremains constant after a set period of time (e.g., 5 seconds), then theparameter may have reached its asymptotic value.

Rate of change information also is useful in determining when a steadystate has been achieved, thus signaling a next step in a process. Forexample, during clamping, when tissue compression reaches a steadystate—e.g., no significant rate of change occurs after a set period oftime—the microcontroller can send a signal to the display alerting theclinician to start the next step in the operation, such as staplefiring. Alternatively, the microcontroller can be programmed toautomatically start the next stage of operation (e.g., staple firing)once a steady state is reached.

Similarly, impedance rate of change can be combined with strain in theanvil to relate force and compression. The rate of change would allowthe device to determine the tissue type rather than merely measure thecompression value. For example, stomach and lung sometimes have similarthicknesses, and even similar compressive properties if the lung iscalcified.

The combination of one or more sensed parameters with derived parametersprovides more reliable and accurate assessment of tissue types andtissue health, and allows for better device monitoring, control, andclinician feedback.

FIG. 53 illustrates one embodiment of an end effector 152000 comprisinga first sensor 152008 a and a second sensor 152008 b. The end effector152000 is similar to the end effector 150300 described above. The endeffector 152000 comprises a first jaw member, or anvil, 152002 pivotallycoupled to a second jaw member 152004. The second jaw member 152004 isconfigured to receive a staple cartridge 152006 therein. The staplecartridge 152006 comprises a plurality of staples (not shown). Theplurality of staples is deployable from the staple cartridge 152006during a surgical operation. The end effector 152000 comprises a firstsensor 152008 a. The first sensor 152008 a is configured to measure oneor more parameters of the end effector 152000. For example, in oneembodiment, the first sensor 152008 a is configured to measure the gap152010 between the anvil 152002 and the second jaw member 152004. Thefirst sensor 152008 a may comprise, for example, a Hall effect sensorconfigured to detect a magnetic field generated by a magnet 152012embedded in the second jaw member 152004 and/or the staple cartridge152006. As another example, in one embodiment, the first sensor 152008 ais configured to measure one or more forces exerted on the anvil 152002by the second jaw member 152004 and/or tissue clamped between the anvil152002 and the second jaw member 152004.

The end effector 152000 comprises a second sensor 152008 b. The secondsensor 152008 b is configured to measure one or more parameters of theend effector 152000. For example, in various embodiments, the secondsensor 152008 b may comprise a strain gauge configured to measure themagnitude of the strain in the anvil 152002 during a clamped condition.The strain gauge provides an electrical signal whose amplitude varieswith the magnitude of the strain. In various embodiments, the firstsensor 152008 a and/or the second sensor 152008 b may comprise, forexample, a magnetic sensor such as, for example, a Hall effect sensor, astrain gauge, a pressure sensor, a force sensor, an inductive sensorsuch as, for example, an eddy current sensor, a resistive sensor, acapacitive sensor, an optical sensor, and/or any other suitable sensorfor measuring one or more parameters of the end effector 152000. Thefirst sensor 152008 a and the second sensor 152008 b may be arranged ina series configuration and/or a parallel configuration. In a seriesconfiguration, the second sensor 152008 b may be configured to directlyaffect the output of the first sensor 152008 a. In a parallelconfiguration, the second sensor 152008 b may be configured toindirectly affect the output of the first sensor 152008 a.

In one embodiment, the one or more parameters measured by the firstsensor 152008 a are related to the one or more parameters measured bythe second sensor 152008 b. For example, in one embodiment, the firstsensor 152008 a is configured to measure the gap 152010 between theanvil 152002 and the second jaw member 152004. The gap 152010 isrepresentative of the thickness and/or compressibility of a tissuesection clamped between the anvil 152002 and the staple cartridge152006. The first sensor 152008 a may comprise, for example, a Halleffect sensor configured to detect a magnetic field generated by themagnet 152012 coupled to the second jaw member 152004 and/or the staplecartridge 152006. Measuring at a single location accurately describesthe compressed tissue thickness for a calibrated full bit of tissue, butmay provide inaccurate results when a partial bite of tissue is placedbetween the anvil 152002 and the second jaw member 152004. A partialbite of tissue, either a proximal partial bite or a distal partial bite,changes the clamping geometry of the anvil 152002.

In some embodiments, the second sensor 152008 b is configured to detectone or more parameters indicative of a type of tissue bite, for example,a full bite, a partial proximal bite, and/or a partial distal bite. Themeasurement of the second sensor 152008 b may be used to adjust themeasurement of the first sensor 152008 a to accurately represent aproximal or distal positioned partial bite's true compressed tissuethickness. For example, in one embodiment, the second sensor 152008 bcomprises a strain gauge, such as, for example, a micro-strain gauge,configured to monitor the amplitude of the strain in the anvil during aclamped condition. The amplitude of the strain of the anvil 152002 isused to modify the output of the first sensor 152008 a, for example, aHall effect sensor, to accurately represent a proximal or distalpositioned partial bite's true compressed tissue thickness. The firstsensor 152008 a and the second sensor 152008 b may be measured inreal-time during a clamping operation. Real-time measurement allows timebased information to be analyzed, for example, by a primary processor(e.g., processor 462 (FIG. 12), for example), and used to select one ormore algorithms and/or look-up tables to recognize tissuecharacteristics and clamping positioning to dynamically adjust tissuethickness measurements.

In some embodiments, the thickness measurement of the first sensor152008 a may be provided to an output device of a surgical instrument150010 coupled to the end effector 152000. For example, in oneembodiment, the end effector 152000 is coupled to the surgicalinstrument 150010 comprising a display (e.g., display 473 (FIG. 12), forexample). The measurement of the first sensor 152008 a is provided to aprocessor, for example, the primary processor. The primary processoradjusts the measurement of the first sensor 152008 a based on themeasurement of the second sensor 152008 b to reflect the true tissuethickness of a tissue section clamped between the anvil 152002 and thestaple cartridge 152006. The primary processor outputs the adjustedtissue thickness measurement and an indication of full or partial biteto the display. An operator may determine whether or not to deploy thestaples in the staple cartridge 152006 based on the displayed values.

In some embodiments, the first sensor 152008 a and the second sensor152008 b may be located in different environments, such as, for example,the first sensor 152008 a being located within a patient at a treatmentsite and the second sensor 152008 b being located externally to thepatient. The second sensor 152008 b may be configured to calibrateand/or modify the output of the first sensor 152008 a. The first sensor152008 a and/or the second sensor 152008 b may comprise, for example, anenvironmental sensor. Environmental sensors may comprise, for example,temperature sensors, humidity sensors, pressure sensors, and/or anyother suitable environmental sensor.

FIG. 54 is a logic diagram illustrating one embodiment of a process152020 for adjusting the measurement of a first sensor 152008 a based oninput from a second sensor 152008 b. A first signal 152022 a is capturedby the first sensor 152008 a. The first signal 152022 a may beconditioned based on one or more predetermined parameters, such as, forexample, a smoothing function, a look-up table, and/or any othersuitable conditioning parameters. A second signal 152022 b is capturedby the second sensor 152008 b. The second signal 152022 b may beconditioned based on one or more predetermined conditioning parameters.The first signal 152022 a and the second signal 152022 b are provided toa processor, such as, for example, the primary processor. The processoradjusts the measurement of the first sensor 152008 a, as represented bythe first signal 152022 a, based on the second signal 152022 b from thesecond sensor. For example, in one embodiment, the first sensor 152008 acomprises a Hall effect sensor and the second sensor 152008 b comprisesa strain gauge. The distance measurement of the first sensor 152008 a isadjusted by the amplitude of the strain measured by the second sensor152008 b to determine the fullness of the bite of tissue in the endeffector 152000. The adjusted measurement is displayed 152026 to anoperator by, for example, a display embedded in the surgical instrument150010.

FIG. 55 is a logic diagram illustrating one embodiment of a process152030 for determining a look-up table for a first sensor 152008 a basedon the input from a second sensor 152008 b. The first sensor 152008 acaptures a signal 152022 a indicative of one or more parameters of theend effector 152000. The first signal 152022 a may be conditioned basedon one or more predetermined parameters, such as, for example, asmoothing function, a look-up table, and/or any other suitableconditioning parameters. A second signal 152022 b is captured by thesecond sensor 152008 b. The second signal 152022 b may be conditionedbased on one or more predetermined conditioning parameters. The firstsignal 152022 a and the second signal 152022 b are provided to aprocessor, such as, for example, the primary processor. The processorselects a look-up table from one or more available look-up tables 152034a, 152034 b based on the value of the second signal. The selectedlook-up table is used to convert the first signal into a thicknessmeasurement of the tissue located between the anvil 152002 and thestaple cartridge 152006. The adjusted measurement is displayed 152026 toan operator by, for example, a display embedded in the surgicalinstrument 150010.

FIG. 56 is a logic diagram illustrating one embodiment of a process152040 for calibrating a first sensor 152008 a in response to an inputfrom a second sensor 152008 b. The first sensor 152008 a is configuredto capture a signal 152022 a indicative of one or more parameters of theend effector 152000. The first signal 152022 a may be conditioned basedon one or more predetermined parameters, such as, for example, asmoothing function, a look-up table, and/or any other suitableconditioning parameters. A second signal 152022 b is captured by thesecond sensor 152008 b. The second signal 152022 b may be conditionedbased on one or more predetermined conditioning parameters. The firstsignal 152022 a and the second signal 152022 b are provided to aprocessor, such as, for example, the primary processor. The primaryprocessor calibrates 152042 the first signal 152022 a in response to thesecond signal 152022 b. The first signal 152022 a is calibrated 152042to reflect the fullness of the bite of tissue in the end effector152000. The calibrated signal is displayed 152026 to an operator by, forexample, a display embedded in the surgical instrument 150010.

FIG. 57 is a logic diagram illustrating one embodiment of a process152050 for determining and displaying the thickness of a tissue sectionclamped between the anvil 152002 and the staple cartridge 152006 of theend effector 152000. The process 152050 comprises obtaining a Halleffect voltage 152052, for example, through a Hall effect sensor locatedat the distal tip of the anvil 152002. The Hall effect voltage 152052 isprovided to an analog to digital convertor 152054 and converted into adigital signal. The digital signal is provided to a processor, such as,for example, the primary processor. The primary processor calibrates152056 the curve input of the Hall effect voltage 152052 signal. Astrain gauge 152058, such as, for example, a micro-strain gauge, isconfigured to measure one or more parameters of the end effector 152000,such as, for example, the amplitude of the strain exerted on the anvil152002 during a clamping operation. The measured strain is converted152060 to a digital signal and provided to the processor, such as, forexample, the primary processor. The primary processor uses one or morealgorithms and/or lookup tables to adjust the Hall effect voltage 152052in response to the strain measured by the strain gauge 152058 to reflectthe true thickness and fullness of the bite of tissue clamped by theanvil 152002 and the staple cartridge 152006. The adjusted thickness isdisplayed 152026 to an operator by, for example, a display embedded inthe surgical instrument 150010.

In some embodiments, the surgical instrument can further comprise a loadcell or sensor 152082. The load sensor 152082 can be located, forinstance, in the shaft assembly 150200, described above, or in thehousing 150012, also described above. FIG. 58 is a logic diagramillustrating one embodiment of a process 152070 for determining anddisplaying the thickness of a tissue section clamped between the anvil152002 and the staple cartridge 152006 of the end effector 152000. Theprocess comprises obtaining a Hall effect voltage 152072, for example,through a Hall effect sensor located at the distal tip of the anvil152002. The Hall effect voltage 152072 is provided to an analog todigital convertor 152074 and converted into a digital signal. Thedigital signal is provided to a processor, such as, for example, theprimary processor. The primary processor calibrates 152076 the curveinput of the Hall effect voltage 152072 signal. A strain gauge 152078,such as, for example, a micro-strain gauge, is configured to measure oneor more parameters of the end effector 152000, such as, for example, theamplitude of the strain exerted on the anvil 152002 during a clampingoperation. The measured strain is converted 152080 to a digital signaland provided to the processor, such as, for example, the primaryprocessor. The load sensor 152082 measures the clamping force of theanvil 152002 against the staple cartridge 152006. The measured clampingforce is converted 152084 to a digital signal and provided to theprocessor, such as for example, the primary processor. The primaryprocessor uses one or more algorithms and/or lookup tables to adjust theHall effect voltage 152072 in response to the strain measured by thestrain gauge 152078 and the clamping force measured by the load sensor152082 to reflect the true thickness and fullness of the bite of tissueclamped by the anvil 152002 and the staple cartridge 152006. Theadjusted thickness is displayed 152026 to an operator by, for example, adisplay embedded in the surgical instrument 150010.

FIG. 59 is a graph 152090 illustrating an adjusted Hall effect thicknessmeasurement 152092 compared to an unmodified Hall effect thicknessmeasurement 152094. As shown in FIG. 59, the unmodified Hall effectthickness measurement 152094 indicates a thicker tissue measurement, asthe single sensor is unable to compensate for partial distal/proximalbites that result in incorrect thickness measurements. The adjustedthickness measurement 152092 is generated by, for example, the process152050 illustrated in FIG. 57. The adjusted Hall effect thicknessmeasurement 152092 is calibrated based on input from one or moreadditional sensors, such as, for example, a strain gauge. The adjustedHall effect thickness 152092 reflects the true thickness of the tissuelocated between an anvil 152002 and a staple cartridge 152006.

FIG. 60 illustrates one embodiment of an end effector 152100 comprisinga first sensor 152108 a and a second sensor 152108 b. The end effector152100 is similar to the end effector 152000 illustrated in FIG. 53. Theend effector 152100 comprises a first jaw member, or anvil, 152102pivotally coupled to a second jaw member 152104. The second jaw member152104 is configured to receive a staple cartridge 152106 therein. Theend effector 152100 comprises a first sensor 152108 a coupled to theanvil 152102. The first sensor 152108 a is configured to measure one ormore parameters of the end effector 152100, such as, for example, thegap 152110 between the anvil 152102 and the staple cartridge 152106. Thegap 152110 may correspond to, for example, a thickness of tissue clampedbetween the anvil 152102 and the staple cartridge 152106. The firstsensor 152108 a may comprise any suitable sensor for measuring one ormore parameters of the end effector. For example, in variousembodiments, the first sensor 152108 a may comprise a magnetic sensor,such as a Hall effect sensor, a strain gauge, a pressure sensor, aninductive sensor, such as an eddy current sensor, a resistive sensor, acapacitive sensor, an optical sensor, and/or any other suitable sensor.

In some embodiments, the end effector 152100 comprises a second sensor152108 b. The second sensor 152108 b is coupled to second jaw member152104 and/or the staple cartridge 152106. The second sensor 152108 b isconfigured to detect one or more parameters of the end effector 152100.For example, in some embodiments, the second sensor 152108 b isconfigured to detect one or more instrument conditions such as, forexample, a color of the staple cartridge 152106 coupled to the secondjaw member 152104, a length of the staple cartridge 152106, a clampingcondition of the end effector 152100, the number of uses/number ofremaining uses of the end effector 152100 and/or the staple cartridge152106, and/or any other suitable instrument condition. The secondsensor 152108 b may comprise any suitable sensor for detecting one ormore instrument conditions, such as, for example, a magnetic sensor,such as a Hall effect sensor, a strain gauge, a pressure sensor, aninductive sensor, such as an eddy current sensor, a resistive sensor, acapacitive sensor, an optical sensor, and/or any other suitable sensor.

The end effector 152100 may be used in conjunction with any of theprocesses shown in FIGS. 54 to 57. For example, in one embodiment, inputfrom the second sensor 152108 b may be used to calibrate the input ofthe first sensor 152108 a. The second sensor 152108 b may be configuredto detect one or more parameters of the staple cartridge 152106, suchas, for example, the color and/or length of the staple cartridge 152106.The detected parameters, such as the color and/or the length of thestaple cartridge 152106, may correspond to one or more properties of thecartridge, such as, for example, the height of the cartridge deck, thethickness of tissue useable/optimal for the staple cartridge, and/or thepattern of the staples in the staple cartridge 152106. The knownparameters of the staple cartridge 152106 may be used to adjust thethickness measurement provided by the first sensor 152108 a. Forexample, if the staple cartridge 152106 has a higher deck height, thethickness measurement provided by the first sensor 152108 a may bereduced to compensate for the added deck height. The adjusted thicknessmay be displayed to an operator, for example, through a display coupledto the surgical instrument 150010.

FIG. 61 illustrates one embodiment of an end effector 152150 comprisinga first sensor 152158 and a plurality of second sensors 152160 a, 152160b. The end effector 152150 comprises a first jaw member, or anvil,152152 and a second jaw member 152154. The second jaw member 152154 isconfigured to receive a staple cartridge 152156. The anvil 152152 ispivotally moveable with respect to the second jaw member 152154 to clamptissue between the anvil 152152 and the staple cartridge 152156. Theanvil comprises a first sensor 152158. The first sensor 152158 isconfigured to detect one or more parameters of the end effector 152150,such as, for example, the gap 152110 between the anvil 152152 and thestaple cartridge 152156. The gap 152110 may correspond to, for example,a thickness of tissue clamped between the anvil 152152 and the staplecartridge 152156. The first sensor 152158 may comprise any suitablesensor for measuring one or more parameters of the end effector. Forexample, in various embodiments, the first sensor 152158 may comprise amagnetic sensor, such as a Hall effect sensor, a strain gauge, apressure sensor, an inductive sensor, such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor.

In some embodiments, the end effector 152150 comprises a plurality ofsecondary sensors 152160 a, 152160 b. The secondary sensors 152160 a,152160 b are configured to detect one or more parameters of the endeffector 152150. For example, in some embodiments, the secondary sensors152160 a, 152160 b are configured to measure an amplitude of strainexerted on the anvil 152152 during a clamping procedure. In variousembodiments, the secondary sensors 152160 a, 152160 b may comprise amagnetic sensor, such as a Hall effect sensor, a strain gauge, apressure sensor, an inductive sensor, such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor. The secondary sensors 152160 a, 152160 b may beconfigured to measure one or more identical parameters at differentlocations of the anvil 152152, different parameters at identicallocations on the anvil 152152, and/or different parameters at differentlocations on the anvil 152152.

FIG. 62 is a logic diagram illustrating one embodiment of a process152170 for adjusting a measurement of a first sensor 152158 in responseto a plurality of secondary sensors 152160 a, 152160 b. In oneembodiment, a Hall effect voltage is obtained 152172, for example, by aHall effect sensor. The Hall effect voltage is converted 152174 by ananalog to digital convertor. The converted Hall effect voltage signal iscalibrated 152176. The calibrated curve represents the thickness of atissue section located between the anvil 152152 and the staple cartridge152156. A plurality of secondary measurements are obtained 152178 a,152178 b by a plurality of secondary sensors, such as, for example, aplurality of strain gauges. The input of the strain gauges is converted152180 a, 152180 b into one or more digital signals, for example, by aplurality of electronic μStrain conversion circuits. The calibrated Halleffect voltage and the plurality of secondary measurements are providedto a processor, such as, for example, the primary processor. The primaryprocessor utilizes the secondary measurements to adjust 152182 the Halleffect voltage, for example, by applying an algorithm and/or utilizingone or more look-up tables. The adjusted Hall effect voltage representsthe true thickness and fullness of the bite of tissue clamped by theanvil 152152 and the staple cartridge 152156. The adjusted thickness isdisplayed 152026 to an operator by, for example, a display embedded inthe surgical instrument 150010.

FIG. 63 illustrates one embodiment of a circuit 152190 configured toconvert signals from the first sensor 152158 and the plurality ofsecondary sensors 152160 a, 152160 b into digital signals receivable bya processor, such as, for example, the primary processor. The circuit152190 comprises an analog-to-digital convertor 152194. In someembodiments, the analog-to-digital convertor 152194 comprises a4-channel, 18-bit analog to digital convertor. Those skilled in the artwill recognize that the analog-to-digital convertor 152194 may compriseany suitable number of channels and/or bits to convert one or moreinputs from analog to digital signals. The circuit 152190 comprises oneor more level shifting resistors 152196 configured to receive an inputfrom the first sensor 152158, such as, for example, a Hall effectsensor. The level shifting resistors 152196 adjust the input from thefirst sensor, shifting the value to a higher or lower voltage dependingon the input. The level shifting resistors 152196 provide thelevel-shifted input from the first sensor 152158 to theanalog-to-digital convertor.

In some embodiments, a plurality of secondary sensors 152160 a, 152160 bare coupled to a plurality of bridges 152192 a, 152192 b within thecircuit 152190. The plurality of bridges 152192 a, 152192 b may providefiltering of the input from the plurality of secondary sensors 152160 a,152160 b. After filtering the input signals, the plurality of bridges152192 a, 152192 b provide the inputs from the plurality of secondarysensors 152160 a, 152160 b to the analog-to-digital convertor 152194. Insome embodiments, a switch 152198 coupled to one or more level shiftingresistors may be coupled to the analog-to-digital convertor 152194. Theswitch 152198 is configured to calibrate one or more of the inputsignals, such as, for example, an input from a Hall effect sensor. Theswitch 152198 may be engaged to provide one or more level shiftingsignals to adjust the input of one or more of the sensors, such as, forexample, to calibrate the input of a Hall effect sensor. In someembodiments, the adjustment is not necessary, and the switch 152198 isleft in the open position to decouple the level shifting resistors. Theswitch 152198 is coupled to the analog-to-digital convertor 152194. Theanalog-to-digital convertor 152194 provides an output to one or moreprocessors, such as, for example, the primary processor. The primaryprocessor calculates one or more parameters of the end effector 152150based on the input from the analog-to-digital convertor 152194. Forexample, in one embodiment, the primary processor calculates a thicknessof tissue located between the anvil 152152 and the staple cartridge152156 based on input from one or more sensors 152158, 152160 a, 152160b.

FIG. 64 illustrates one embodiment of an end effector 152200 comprisinga plurality of sensors 152208 a-152208 d. The end effector 152200comprises an anvil 152202 pivotally coupled to a second jaw member152204. The second jaw member 152204 is configured to receive a staplecartridge 152206 therein. The anvil 152202 comprises a plurality ofsensors 152208 a-152208 d thereon. The plurality of sensors 152208a-152208 d is configured to detect one or more parameters of the endeffector 152200, such as, for example, the anvil 152202. The pluralityof sensors 152208 a-152208 d may comprise one or more identical sensorsand/or different sensors. The plurality of sensors 152208 a-152208 d maycomprise, for example, magnetic sensors, such as a Hall effect sensor,strain gauges, pressure sensors, inductive sensors, such as an eddycurrent sensor, resistive sensors, capacitive sensors, optical sensors,and/or any other suitable sensors or combination thereof. For example,in one embodiment, the plurality of sensors 152208 a-152208 d maycomprise a plurality of strain gauges.

In one embodiment, the plurality of sensors 152208 a-152208 d allows arobust tissue thickness sensing process to be implemented. By detectingvarious parameters along the length of the anvil 152202, the pluralityof sensors 152208 a-152208 d allow a surgical instrument, such as, forexample, the surgical instrument 150010, to calculate the tissuethickness in the jaws regardless of the bite, for example, a partial orfull bite. In some embodiments, the plurality of sensors 152208 a-152208d comprises a plurality of strain gauges. The plurality of strain gaugesis configured to measure the strain at various points on the anvil152202. The amplitude and/or the slope of the strain at each of thevarious points on the anvil 152202 can be used to determine thethickness of tissue in between the anvil 152202 and the staple cartridge152206. The plurality of strain gauges may be configured to optimizemaximum amplitude and/or slope differences based on clamping dynamics todetermine thickness, tissue placement, and/or material properties of thetissue. Time based monitoring of the plurality of sensors 152208a-152208 d during clamping allows a processor, such as, for example, theprimary processor, to utilize algorithms and look-up tables to recognizetissue characteristics and clamping positions and dynamically adjust theend effector 152200 and/or tissue clamped between the anvil 152202 andthe staple cartridge 152206.

FIG. 65 is a logic diagram illustrating one embodiment of a process152220 for determining one or more tissue properties based on aplurality of sensors 152208 a-152208 d. In one embodiment, a pluralityof sensors 152208 a-152208 d generate 152222 a-152222 d a plurality ofsignals indicative of one or more parameters of the end effector 152200.The plurality of generated signals is converted 152224 a-152224 d todigital signals and provided to a processor. For example, in oneembodiment comprising a plurality of strain gauges, a plurality ofelectronic μStrain (micro-strain) conversion circuits convert 152224a-152224 d the strain gauge signals to digital signals. The digitalsignals are provided to a processor, such as, for example, the primaryprocessor. The primary processor determines 152226 one or more tissuecharacteristics based on the plurality of signals. The processor maydetermine the one or more tissue characteristics by applying analgorithm and/or a look-up table. The one or more tissue characteristicsare displayed 152026 to an operator, for example, by a display embeddedin the surgical instrument 150010.

FIG. 66 illustrates one embodiment of an end effector 152250 comprisinga plurality of sensors 152260 a-152260 d coupled to a second jaw member3254. The end effector 152250 comprises an anvil 152252 pivotallycoupled to a second jaw member 152254. The anvil 152252 is moveablerelative to the second jaw member 152254 to clamp one or more materials,such as, for example, a tissue section 152264, therebetween. The secondjaw member 152254 is configured to receive a staple cartridge 152256. Afirst sensor 152258 is coupled to the anvil 152252. The first sensor isconfigured to detect one or more parameters of the end effector 152150,such as, for example, the gap 152110 between the anvil 152252 and thestaple cartridge 152256. The gap 152110 may correspond to, for example,a thickness of tissue clamped between the anvil 152252 and the staplecartridge 152256. The first sensor 152258 may comprise any suitablesensor for measuring one or more parameters of the end effector. Forexample, in various embodiments, the first sensor 152258 may comprise amagnetic sensor, such as a Hall effect sensor, a strain gauge, apressure sensor, an inductive sensor, such as an eddy current sensor, aresistive sensor, a capacitive sensor, an optical sensor, and/or anyother suitable sensor.

A plurality of secondary sensors 152260 a-152260 d is coupled to thesecond jaw member 152254. The plurality of secondary sensors 152260a-152260 d may be formed integrally with the second jaw member 152254and/or the staple cartridge 152256. For example, in one embodiment, theplurality of secondary sensors 152260 a-152260 d is disposed on an outerrow of the staple cartridge 152256 (see FIG. 67). The plurality ofsecondary sensors 152260 a-152260 d are configured to detect one or moreparameters of the end effector 152250 and/or a tissue section 152264clamped between the anvil 152252 and the staple cartridge 152256. Theplurality of secondary sensors 152260 a-152260 d may comprise anysuitable sensors for detecting one or more parameters of the endeffector 152250 and/or the tissue section 152264, such as, for example,magnetic sensors, such as a Hall effect sensor, strain gauges, pressuresensors, inductive sensors, such as an eddy current sensor, resistivesensors, capacitive sensors, optical sensors, and/or any other suitablesensors or combination thereof. The plurality of secondary sensors152260 a-152260 d may comprise identical sensors and/or differentsensors.

In some embodiments, the plurality of secondary sensors 152260 a-152260d comprises dual purpose sensors and tissue stabilizing elements. Theplurality of secondary sensors 152260 a-152260 d comprise electrodesand/or sensing geometries configured to create a stabilized tissuecondition when the plurality of secondary sensors 152260 a-152260 d areengaged with a tissue section 152264, such as, for example, during aclamping operation. In some embodiments, one or more of the plurality ofsecondary sensors 152260 a-152260 d may be replaced with non-sensingtissue stabilizing elements. The secondary sensors 152260 a-152260 dcreate a stabilized tissue condition by controlling tissue flow, stapleformation, and/or other tissue conditions during a clamping, stapling,and/or other treatment process.

FIG. 67 illustrates one embodiment of a staple cartridge 152270comprising a plurality of sensors 152272 a-152272 h formed integrallytherein. The staple cartridge 152270 comprises a plurality of rowscontaining a plurality of holes for storing staples therein. One or moreof the holes in the outer row 152278 are replaced with one of theplurality of sensors 152272 a-152272 h. A cut-away section is shown toillustrate a sensor 152272 f coupled to a sensor wire 152276 b. Thesensor wires 152276 a, 152276 b may comprise a plurality of wires forcoupling the plurality of sensors 152272 a-152272 h to one or morecircuits of a surgical instrument, such as, for example, the surgicalinstrument 150010. In some embodiments, one or more of the plurality ofsensors 152272 a-152272 h comprise dual purpose sensor and tissuestabilizing elements having electrodes and/or sensing geometriesconfigured to provide tissue stabilization. In some embodiments, theplurality of sensors 152272 a-152272 h may be replaced with and/orco-populated with a plurality of tissue stabilizing elements. Tissuestabilization may be provided by, for example, controlling tissue flowand/or staple formation during a clamping and/or stapling process. Theplurality of sensors 152272 a-152272 h provide signals to one or morecircuits of the surgical instrument 150010 to enhance feedback ofstapling performance and/or tissue thickness sensing.

FIG. 68 is a logic diagram illustrating one embodiment of a process152280 for determining one or more parameters of a tissue section 152264clamped within an end effector, such as, for example, the end effector152250 illustrated in FIG. 66. In one embodiment, a first sensor 152258is configured to detect one or more parameters of the end effector152250 and/or a tissue section 152264 located between the anvil 152252and the staple cartridge 152256. A first signal is generated 152282 bythe first sensors 152258. The first signal is indicative of the one ormore parameters detected by the first sensor 152258. One or moresecondary sensors 152260 are configured to detect one or more parametersof the end effector 152250 and/or the tissue section 152264. Thesecondary sensors 152260 may be configured to detect the sameparameters, additional parameters, or different parameters as the firstsensor 152258. Secondary signals 152284 are generated by the secondarysensors 152260. The secondary signals 152284 are indicative of the oneor more parameters detected by the secondary sensors 152260. The firstsignal and the secondary signals are provided to a processor, such as,for example, the primary processor. The processor adjusts 152286 thefirst signal generated by the first sensor 152258 based on inputgenerated by the secondary sensors 152260. The adjusted signal may beindicative of, for example, the true thickness of a tissue section152264 and the fullness of the bite. The adjusted signal is displayed152026 to an operator by, for example, a display embedded in thesurgical instrument 150010.

FIG. 69 illustrates one embodiment of an end effector 152300 comprisinga plurality of redundant sensors 152308 a, 152308 b. The end effector152300 comprises a first jaw member, or anvil, 152302 pivotally coupledto a second jaw member 152304. The second jaw member 152304 isconfigured to receive a staple cartridge 152306 therein. The anvil152302 is moveable with respect to the staple cartridge 152306 to graspa material, such as, for example, a tissue section, between the anvil152302 and the staple cartridge 152306. A plurality of sensors 152308 a,152308 b is coupled to the anvil. The plurality of sensors 152308 a,152308 b are configured to detect one or more parameters of the endeffector 152300 and/or a tissue section located between the anvil 152302and the staple cartridge 152306. In some embodiments, the plurality ofsensors 152308 a, 152308 b are configured to detect a gap 152310 betweenthe anvil 152302 and the staple cartridge 152306. The gap 152310 maycorrespond to, for example, the thickness of tissue located between theanvil 152302 and the staple cartridge 152306. The plurality of sensors152308 a, 152308 b may detect the gap 152310 by, for example, detectinga magnetic field generated by a magnet 152312 coupled to the second jawmember 152304.

In some embodiments, the plurality of sensors 152308 a, 152308 bcomprise redundant sensors. The redundant sensors are configured todetect the same properties of the end effector 152300 and/or a tissuesection located between the anvil 152302 and the staple cartridge152306. The redundant sensors may comprise, for example, Hall effectsensors configured to detect the gap 152310 between the anvil 152302 andthe staple cartridge 152306. The redundant sensors provide signalsrepresentative of one or more parameters allowing a processor, such as,for example, the primary processor, to evaluate the multiple inputs anddetermine the most reliable input. In some embodiments, the redundantsensors are used to reduce noise, false signals, and/or drift. Each ofthe redundant sensors may be measured in real-time during clamping,allowing time-based information to be analyzed and algorithms and/orlook-up tables to recognize tissue characteristics and clampingpositioning dynamically. The input of one or more of the redundantsensors may be adjusted and/or selected to identify the true tissuethickness and bite of a tissue section located between the anvil 152302and the staple cartridge 152306.

FIG. 70 is a logic diagram illustrating one embodiment of a process152320 for selecting the most reliable output from a plurality ofredundant sensors, such as, for example, the plurality of sensors 152308a, 152308 b illustrated in FIG. 69. In one embodiment, a first signal isgenerated by a first sensor 152308 a. The first signal is converted152322 a by an analog-to-digital convertor. One or more additionalsignals are generated by one or more redundant sensors 152308 b. The oneor more additional signals are converted 152322 b by ananalog-to-digital convertor. The converted signals are provided to aprocessor, such as, for example, the primary processor. The primaryprocessor evaluates 152324 the redundant inputs to determine the mostreliable output. The most reliable output may be selected based on oneor more parameters, such as, for example, algorithms, look-up tables,input from additional sensors, and/or instrument conditions. Afterselecting the most reliable output, the processor may adjust the outputbased on one or more additional sensors to reflect, for example, thetrue thickness and bite of a tissue section located between the anvil152302 and the staple cartridge 152306. The adjusted most reliableoutput is displayed 152026 to an operator by, for example, a displayembedded in the surgical instrument 150010.

FIG. 71 illustrates one embodiment of an end effector 152350 comprisinga sensor 152358 comprising a specific sampling rate to limit oreliminate false signals. The end effector 152350 comprises a first jawmember, or anvil, 152352 pivotably coupled to a second jaw member152354. The second jaw member 152354 is configured to receive a staplecartridge 152356 therein. The staple cartridge 152356 contains aplurality of staples that may be delivered to a tissue section locatedbetween the anvil 152352 and the staple cartridge 152356. A sensor152358 is coupled to the anvil 152352. The sensor 152358 is configuredto detect one or more parameters of the end effector 152350, such as,for example, the gap 152364 between the anvil 152352 and the staplecartridge 152356. The gap 152364 may correspond to the thickness of amaterial, such as, for example, a tissue section, and/or the fullness ofa bite of material located between the anvil 152352 and the staplecartridge 152356. The sensor 152358 may comprise any suitable sensor fordetecting one or more parameters of the end effector 152350, such as,for example, a magnetic sensor, such as a Hall effect sensor, a straingauge, a pressure sensor, an inductive sensor, such as an eddy currentsensor, a resistive sensor, a capacitive sensor, an optical sensor,and/or any other suitable sensor.

In one embodiment, the sensor 152358 comprises a magnetic sensorconfigured to detect a magnetic field generated by an electromagneticsource 152360 coupled to the second jaw member 152354 and/or the staplecartridge 152356. The electromagnetic source 152360 generates a magneticfield detected by the sensor 152358. The strength of the detectedmagnetic field may correspond to, for example, the thickness and/orfullness of a bite of tissue located between the anvil 152352 and thestaple cartridge 152356. In some embodiments, the electromagnetic source152360 generates a signal at a known frequency, such as, for example, 1MHz. In other embodiments, the signal generated by the electromagneticsource 152360 may be adjustable based on, for example, the type ofstaple cartridge 152356 installed in the second jaw member 152354, oneor more additional sensor, an algorithm, and/or one or more parameters.

In one embodiment, a signal processor 152362 is coupled to the endeffector 152350, such as, for example, the anvil 152352. The signalprocessor 152362 is configured to process the signal generated by thesensor 152358 to eliminate false signals and to boost the input from thesensor 152358. In some embodiments, the signal processor 152362 may belocated separately from the end effector 152350, such as, for example,in the handle 150014 of the surgical instrument 150010. In someembodiments, the signal processor 152362 is formed integrally withand/or comprises an algorithm executed by a general processor, such as,for example, the primary processor. The signal processor 152362 isconfigured to process the signal from the sensor 152358 at a frequencysubstantially equal to the frequency of the signal generated by theelectromagnetic source 152360. For example, in one embodiment, theelectromagnetic source 152360 generates a signal at a frequency of 1MHz. The signal is detected by the sensor 152358. The sensor 152358generates a signal indicative of the detected magnetic field which isprovided to the signal processor 152362. The signal is processed by thesignal processor 152362 at a frequency of 1 MHz to eliminate falsesignals. The processed signal is provided to a processor, such as, forexample, the primary processor. The primary processor correlates thereceived signal to one or more parameters of the end effector 152350,such as, for example, the gap 152364 between the anvil 152352 and thestaple cartridge 152356.

FIG. 72 is a logic diagram illustrating one embodiment of a process152370 for generating a thickness measurement for a tissue sectionlocated between an anvil and a staple cartridge of an end effector, suchas, for example, the end effector 152350 illustrated in FIG. 71. In oneembodiment of the process 152370, a signal is generated 152372 by amodulated electromagnetic source 152360. The generated signal maycomprise, for example, a 1 MHz signal. A magnetic sensor 152358 isconfigured to detect 152374 the signal generated by the electromagneticsource 152360. The magnetic sensor 152358 generates a signal indicativeof the detected magnetic field and provides the signal to a signalprocessor 152362. The signal processor 152362 processes 152376 thesignal to remove noise, false signals, and/or to boost the signal. Theprocessed signal is provided to an analog-to-digital convertor forconversion 152378 to a digital signal. The digital signal may becalibrated 152380, for example, by application of a calibration curveinput algorithm and/or look-up table. The signal processing 152376,conversion 152378, and calibration 152380 may be performed by one ormore circuits. The calibrated signal is displayed 152026 to a user by,for example, a display formed integrally with the surgical instrument150010.

FIGS. 73 and 74 illustrate one embodiment of an end effector 152400comprising a sensor 152408 for identifying staple cartridges 152406 ofdifferent types. The end effector 152400 comprises a first jaw member oranvil 152402, pivotally coupled to a second jaw member or elongatedchannel 152404. The elongated channel 152404 is configured to operablysupport a staple cartridge 152406 therein. The end effector 152400further comprises a sensor 152408 located in the proximal area. Thesensor 152408 can be any of an optical sensor, a magnetic sensor, anelectrical sensor, or any other suitable sensor.

The sensor 152408 can be operable to detect a property of the staplecartridge 152406 and thereby identify the staple cartridge 152406 type.FIG. 74 illustrates an example where the sensor 152408 is an opticalemitter and detector 152410. The body of the staple cartridge 152406 canbe different colors, such that the color identifies the staple cartridge152406 type. An optical emitter and detector 152410 can be operable tointerrogate the color of the staple cartridge 152406 body. In theillustrated example, the optical emitter and detector 152410 can detectwhite 152412 by receiving reflected light in the red, green, and bluespectrums in equal intensity. The optical emitter and detector 152410can detect red 152414 by receiving very little reflected light in thegreen and blue spectrums while receiving light in the red spectrum ingreater intensity.

Alternately or additionally, the optical emitter and detector 152410, oranother suitable sensor 152408, can interrogate and identify some othersymbol or marking on the staple cartridge 152406. The symbol or markingcan be any one of a barcode, a shape or character, a color-coded emblem,or any other suitable marking. The information read by the sensor 152408can be communicated to a microcontroller in the surgical device 150010,such as for instance a microcontroller (e.g., microcontroller 461 (FIG.12), for example). The microcontroller can be configured to communicateinformation about the staple cartridge 152406 to the operator of theinstrument. For instance, the identified staple cartridge 152406 may notbe appropriate for a given application; in such case, the operator ofthe instrument can be informed, and/or a function of the instrument sinappropriate. In such instance, the microcontroller can optionally beconfigured to disable a function of surgical instrument can be disabled.Alternatively or additionally, the microcontroller can be configured toinform the operator of the surgical instrument 150010 of the parametersof the identified staple cartridge 152406 type, such as for instance thelength of the staple cartridge 152406, or information about the staples,such as the height and length.

FIG. 75 illustrates one aspect of a segmented flexible circuit 153430configured to fixedly attach to a jaw member 153434 of an end effector.The segmented flexible circuit 153430 comprises a distal segment 153432a and lateral segments 153432 b, 153432 c that include individuallyaddressable sensors to provide local tissue presence detection. Thesegments 153432 a, 153432 b, 153432 c are individually addressable todetect tissue and to measure tissue parameters based on individualsensors located within each of the segments 153432 a, 153432 b, 153432c. The segments 153432 a, 153432 b, 153432 c of the segmented flexiblecircuit 153430 are mounted to the jaw member 153434 and are electricallycoupled to an energy source such as an electrical circuit via electricalconductive elements 153436. A Hall effect sensor 153438, or any suitablemagnetic sensor, is located on a distal end of the jaw member 153434.The Hall effect sensor 153438 operates in conjunction with a magnet toprovide a measurement of an aperture defined by the jaw member 153434,which otherwise may be referred to as a tissue gap, as shown withparticularity in FIG. 77. The segmented flexible circuit 153430 may beemployed to measure tissue thickness, force, displacement, compression,tissue impedance, and tissue location within an end effector.

FIG. 76 illustrates one aspect of a segmented flexible circuit 153440configured to mount to a jaw member 153444 of an end effector. Thesegmented flexible circuit 153440 comprises a distal segment 153442 aand lateral segments 153442 b, 153442 c that include individuallyaddressable sensors for tissue control. The segments 153442 a, 153442 b,153442 c are individually addressable to treat tissue and to readindividual sensors located within each of the segments 153442 a, 153442b, 153442 c. The segments 153442 a, 153442 b, 153442 c of the segmentedflexible circuit 153440 are mounted to the jaw member 153444 and areelectrically coupled to an energy source, via electrical conductiveelements 153446. A Hall effect sensor 153448, or other suitable magneticsensor, is provided on a distal end of the jaw member 153444. The Halleffect sensor 153448 operates in conjunction with a magnet to provide ameasurement of an aperture defined by the jaw member 153444 of the endeffector or tissue gap as shown with particularity in FIG. 77. Inaddition, a plurality of lateral asymmetric temperature sensors 153450a, 153450 b are mounted on or formally integrally with the segmentedflexible circuit 153440 to provide tissue temperature feedback to thecontrol circuit. The segmented flexible circuit 153440 may be employedto measure tissue thickness, force, displacement, compression, tissueimpedance, and tissue location within an end effector.

FIG. 77 illustrates one aspect of an end effector 153460 configured tomeasure a tissue gap G_(T). The end effector 153460 comprises a jawmember 153462 and a jaw member 153444. The flexible circuit 153440 asdescribed in FIG. 76 is mounted to the jaw member 153444. The flexiblecircuit 153440 comprises a Hall effect sensor 153448 that operates witha magnet 153464 mounted to the jaw member 153462 to measure the tissuegap G_(T). This technique can be employed to measure the aperturedefined between the jaw member 153444 and the jaw member 153462. The jawmember 153462 may be a staple cartridge.

FIG. 78 illustrates one aspect of an end effector 153470 comprising asegmented flexible circuit 153468. The end effector 153470 comprises ajaw member 153472 and a staple cartridge 153474. The segmented flexiblecircuit 153468 is mounted to the jaw member 153472. Each of the sensorsdisposed within the segments 1-5 are configured to detect the presenceof tissue positioned between the jaw member 153472 and the staplecartridge 153474 and represent tissue zones 1-5. In the configurationshown in FIG. 78, the end effector 153470 is shown in an open positionready to receive or grasp tissue between the jaw member 153472 and thestaple cartridge 153474. The segmented flexible circuit 153468 may beemployed to measure tissue thickness, force, displacement, compression,tissue impedance, and tissue location within the end effector 153470.

FIG. 79 illustrates the end effector 153470 shown in FIG. 78 with thejaw member 153472 clamping tissue 153476 between the jaw members 153472,e.g., the anvil and the staple cartridge. As shown in FIG. 79, thetissue 153476 is positioned between segments 1-3 and represents tissuezones 1-3. Accordingly, tissue 153476 is detected by the sensors insegments 1-3 and the absence of tissue (empty) is detected in section153469 by segments 4-5. The information regarding the presence andabsence of tissue 153476 positioned within certain segments 1-3 and 4-5,respectively, is communicated to a control circuit as described hereinvia interface circuits, for example. The control circuit is configuredto detect tissue located in segments 1-3. It will be appreciated thatthe segments 1-5 may contain any suitable temperature, force/pressure,and/or Hall effect magnetic sensors to measure tissue parameters oftissue located within certain segments 1-5 and electrodes to deliverenergy to tissue located in certain segments 1-5. The segmented flexiblecircuit 153468 may be employed to measure tissue thickness, force,displacement, compression, tissue impedance, and tissue location withinthe end effector 153470.

FIG. 80 is a diagram of an absolute positioning system 153100 that canbe used with a surgical instrument or system in accordance with thepresent disclosure. The absolute positioning system 153100 comprises acontrolled motor drive circuit arrangement comprising a sensorarrangement 153102, in accordance with at least one aspect of thisdisclosure. The sensor arrangement 153102 for an absolute positioningsystem 153100 provides a unique position signal corresponding to thelocation of a displacement member 153111. In one aspect the displacementmember 153111 represents the longitudinally movable drive member coupledto the cutting instrument or knife (e.g., a cutting instrument, anI-beam, and/or I-beam 153514 (FIG. 82)). In other aspects, thedisplacement member 153111 represents a firing member coupled to thecutting instrument or knife, which could be adapted and configured toinclude a rack of drive teeth. In yet another aspect, the displacementmember 153111 represents a firing bar or an I-beam, each of which can beadapted and configured to include a rack of drive teeth.

Accordingly, as used herein, the term displacement member is usedgenerically to refer to any movable member of a surgical instrument orsystem as described herein, such as a drive member, firing member,firing bar, cutting instrument, knife, and/or I-beam, or any elementthat can be displaced. Accordingly, the absolute positioning system153100 can, in effect, track the displacement of the cutting instrumentI-beam 153514 (FIG. 82) by tracking the displacement of a longitudinallymovable drive member. In various other aspects, the displacement member153111 may be coupled to any sensor suitable for measuring displacement.Thus, a longitudinally movable drive member, firing member, the firingbar, or I-beam, or combinations thereof, may be coupled to any suitabledisplacement sensor. Displacement sensors may include contact ornon-contact displacement sensors. Displacement sensors may compriselinear variable differential transformers (LVDT), differential variablereluctance transducers (DVRT), a slide potentiometer, a magnetic sensingsystem comprising a movable magnet and a series of linearly arrangedHall effect sensors, a magnetic sensing system comprising a fixed magnetand a series of movable linearly arranged Hall effect sensors, anoptical sensing system comprising a movable light source and a series oflinearly arranged photo diodes or photo detectors, or an optical sensingsystem comprising a fixed light source and a series of movable linearlyarranged photo diodes or photo detectors, or any combination thereof.

An electric motor 153120 can include a rotatable shaft 153116 thatoperably interfaces with a gear assembly 153114 that is mounted inmeshing engagement with a set, or rack, of drive teeth on thedisplacement member 153111. A sensor element 153126 may be operablycoupled to the gear assembly 153114 such that a single revolution of thesensor element 153126 corresponds to some linear longitudinaltranslation of the displacement member 153111. An arrangement of gearingand sensors 153118 can be connected to the linear actuator via a rackand pinion arrangement or a rotary actuator via a spur gear or otherconnection. A power source 153129 supplies power to the absolutepositioning system 153100 and an output indicator 153128 may display theoutput of the absolute positioning system 153100.

A single revolution of the sensor element 153126 associated with theposition sensor 153112 is equivalent to a longitudinal displacement d₁of the of the displacement member 153111, where d₁ is the longitudinaldistance that the displacement member 153111 moves from point “a” topoint “b” after a single revolution of the sensor element 153126 coupledto the displacement member 153111. The sensor arrangement 153102 may beconnected via a gear reduction that results in the position sensor153112 completing one or more revolutions for the full stroke of thedisplacement member 153111. The position sensor 153112 may completemultiple revolutions for the full stroke of the displacement member153111.

A series of switches 153122 a-153122 n, where n is an integer greaterthan one, may be employed alone or in combination with gear reduction toprovide a unique position signal for more than one revolution of theposition sensor 153112. The state of the switches 153122 a-153122 n arefed back to a controller 153110 that applies logic to determine a uniqueposition signal corresponding to the longitudinal displacement d₁+d₂+ .. . d_(n) of the displacement member 153111. The output 153124 of theposition sensor 153112 is provided to the controller 153110. Theposition sensor 153112 of the sensor arrangement 153102 may comprise amagnetic sensor, an analog rotary sensor like a potentiometer, an arrayof analog Hall-effect elements, which output a unique combination ofposition signals or values. The controller 153110 may be containedwithin a master controller or may be contained within a tool mountingportion housing of a surgical instrument or system in accordance withthe present disclosure.

The absolute positioning system 153100 provides an absolute position ofthe displacement member 153111 upon power up of the surgical instrumentor system without retracting or advancing the displacement member 153111to a reset (zero or home) position as may be required with conventionalrotary encoders that merely count the number of steps forwards orbackwards that the motor 153120 has taken to infer the position of adevice actuator, drive bar, knife, and the like.

The controller 153110 may be programmed to perform various functionssuch as precise control over the speed and position of the knife andarticulation systems. In one aspect, the controller 153110 includes aprocessor 153108 and a memory 153106. The electric motor 153120 may be abrushed DC motor with a gearbox and mechanical links to an articulationor knife system. In one aspect, a motor driver 153110 may be an A3941available from Allegro Microsystems, Inc. Other motor drivers may bereadily substituted for use in the absolute positioning system 153100.

The controller 153110 may be programmed to provide precise control overthe speed and position of the displacement member 153111 andarticulation systems. The controller 153110 may be configured to computea response in the software of the controller 153110. The computedresponse is compared to a measured response of the actual system toobtain an “observed” response, which is used for actual feedbackdecisions. The observed response is a favorable, tuned, value thatbalances the smooth, continuous nature of the simulated response withthe measured response, which can detect outside influences on thesystem.

The absolute positioning system 153100 may comprise and/or be programmedto implement a feedback controller, such as a PID, state feedback, andadaptive controller. A power source 153129 converts the signal from thefeedback controller into a physical input to the system, in this casevoltage. Other examples include pulse width modulation (PWM) of thevoltage, current, and force. Other sensor(s) 153118 may be provided tomeasure physical parameters of the physical system in addition toposition measured by the position sensor 153112. In a digital signalprocessing system, absolute positioning system 153100 is coupled to adigital data acquisition system where the output of the absolutepositioning system 153100 will have finite resolution and samplingfrequency. The absolute positioning system 153100 may comprise a compareand combine circuit to combine a computed response with a measuredresponse using algorithms such as weighted average and theoreticalcontrol loop that drives the computed response towards the measuredresponse. The computed response of the physical system takes intoaccount properties like mass, inertial, viscous friction, inductanceresistance, etc., to predict what the states and outputs of the physicalsystem will be by knowing the input.

The motor driver 153110 may be an A3941 available from AllegroMicrosystems, Inc. The A3941 driver 153110 is a full-bridge controllerfor use with external N-channel power metal oxide semiconductor fieldeffect transistors (MOSFETs) specifically designed for inductive loads,such as brush DC motors. The driver 153110 comprises a unique chargepump regulator provides full (>10 V) gate drive for battery voltagesdown to 7 V and allows the A3941 to operate with a reduced gate drive,down to 5.5 V. A bootstrap capacitor may be employed to provide theabove-battery supply voltage required for N-channel MOSFETs. An internalcharge pump for the high-side drive allows DC (100% duty cycle)operation. The full bridge can be driven in fast or slow decay modesusing diode or synchronous rectification. In the slow decay mode,current recirculation can be through the high-side or the lowside FETs.The power FETs are protected from shoot-through by resistor adjustabledead time. Integrated diagnostics provide indication of undervoltage,overtemperature, and power bridge faults, and can be configured toprotect the power MOSFETs under most short circuit conditions. Othermotor drivers may be readily substituted for use in the absolutepositioning system 153100.

FIG. 81 is a diagram of a position sensor 153200 for an absolutepositioning system 153100′ comprising a magnetic rotary absolutepositioning system, in accordance with at least one aspect of thisdisclosure. The absolute positioning system 153100′ is similar in manyrespects to the absolute positioning system 153100. The position sensor153200 may be implemented as an AS5055EQFT single-chip magnetic rotaryposition sensor available from Austria Microsystems, AG. The positionsensor 153200 is interfaced with the controller 153110 to provide theabsolute positioning system 153100′. The position sensor 153200 is alow-voltage and low-power component and includes four Hall-effectelements 153228A, 153228B, 153228C, 153228D in an area 153230 of theposition sensor 153200 that is located above a magnet positioned on arotating element associated with a displacement member such as, forexample, a knife drive gear and/or a closure drive gear such that thedisplacement of a firing member and/or a closure member can be preciselytracked. A high-resolution ADC 153232 and a smart power managementcontroller 153238 are also provided on the chip. A CORDIC processor153236 (for Coordinate Rotation Digital Computer), also known as thedigit-by-digit method and Volder's algorithm, is provided to implement asimple and efficient algorithm to calculate hyperbolic and trigonometricfunctions that require only addition, subtraction, bitshift, and tablelookup operations. The angle position, alarm bits, and magnetic fieldinformation are transmitted over a standard serial communicationinterface such as an SPI interface 153234 to the controller 153110. Theposition sensor 153200 provides 12 or 14 bits of resolution. Theposition sensor 153200 may be an AS5055 chip provided in a small QFN16-pin 4×4×0.85 mm package.

The Hall-effect elements 153228A, 153228B, 153228C, 153228D are locateddirectly above the rotating magnet. The Hall-effect is a well-knowneffect and for expediency will not be described in detail herein,however, generally, the Hall-effect produces a voltage difference (theHall voltage) across an electrical conductor transverse to an electriccurrent in the conductor and a magnetic field perpendicular to thecurrent. A Hall coefficient is defined as the ratio of the inducedelectric field to the product of the current density and the appliedmagnetic field. It is a characteristic of the material from which theconductor is made, since its value depends on the type, number, andproperties of the charge carriers that constitute the current. In theAS5055 position sensor 153200, the Hall-effect elements 153228A,153228B, 153228C, 153228D are capable producing a voltage signal that isindicative of the absolute position of the magnet in terms of the angleover a single revolution of the magnet. This value of the angle, whichis unique position signal, is calculated by the CORDIC processor 153236is stored onboard the AS5055 position sensor 153200 in a register ormemory. The value of the angle that is indicative of the position of themagnet over one revolution is provided to the controller 153110 in avariety of techniques, e.g., upon power up or upon request by thecontroller 153110.

The AS5055 position sensor 153200 requires only a few externalcomponents to operate when connected to the controller 153110. Six wiresare needed for a simple application using a single power supply: twowires for power and four wires 153240 for the SPI interface 153234 withthe controller 153110. A seventh connection can be added in order tosend an interrupt to the controller 153110 to inform that a new validangle can be read. Upon power-up, the AS5055 position sensor 153200performs a full power-up sequence including one angle measurement. Thecompletion of this cycle is indicated as an INT output 153242, and theangle value is stored in an internal register. Once this output is set,the AS5055 position sensor 153200 suspends to sleep mode. The controller153110 can respond to the INT request at the INT output 153242 byreading the angle value from the AS5055 position sensor 153200 over theSPI interface 153234. Once the angle value is read by the controller153110, the INT output 153242 is cleared again. Sending a “read angle”command by the SPI interface 153234 by the controller 153110 to theposition sensor 153200 also automatically powers up the chip and startsanother angle measurement. As soon as the controller 153110 hascompleted reading of the angle value, the INT output 153242 is clearedand a new result is stored in the angle register. The completion of theangle measurement is again indicated by setting the INT output 153242and a corresponding flag in the status register.

Due to the measurement principle of the AS5055 position sensor 153200,only a single angle measurement is performed in very short time (˜600μs) after each power-up sequence. As soon as the measurement of oneangle is completed, the AS5055 position sensor 153200 suspends topower-down state. An on-chip filtering of the angle value by digitalaveraging is not implemented, as this would require more than one anglemeasurement and, consequently, a longer power-up time that is notdesired in low-power applications. The angle jitter can be reduced byaveraging of several angle samples in the controller 153110. Forexample, an averaging of four samples reduces the jitter by 6 dB (50%).

FIG. 82 is a section view of an end effector 153502 showing an I-beam153514 firing stroke relative to tissue 153526 grasped within the endeffector 153502, in accordance with at least one aspect of thisdisclosure. The end effector 153502 is configured to operate with any ofthe surgical instruments or systems in accordance with the presentdisclosure. The end effector 153502 comprises an anvil 153516 and anelongated channel 153503 with a staple cartridge 153518 positioned inthe elongated channel 153503. A firing bar 153520 is translatabledistally and proximally along a longitudinal axis 153515 of the endeffector 153502. When the end effector 153502 is not articulated, theend effector 153502 is in line with the shaft of the instrument. AnI-beam 153514 comprising a cutting edge 153509 is illustrated at adistal portion of the firing bar 153520. A wedge sled 153513 ispositioned in the staple cartridge 153518. As the I-beam 153514translates distally, the cutting edge 153509 contacts and may cut tissue153526 positioned between the anvil 153516 and the staple cartridge153518. Also, the I-beam 153514 contacts the wedge sled 153513 andpushes it distally, causing the wedge sled 153513 to contact stapledrivers 153511. The staple drivers 153511 may be driven up into staples153505, causing the staples 153505 to advance through tissue and intopockets 153507 defined in the anvil 153516, which shape the staples153505.

An example I-beam 153514 firing stroke is illustrated by a chart 153529aligned with the end effector 153502. Example tissue 153526 is alsoshown aligned with the end effector 153502. The firing member stroke maycomprise a stroke begin position 153527 and a stroke end position153528. During an I-beam 153514 firing stroke, the I-beam 153514 may beadvanced distally from the stroke begin position 153527 to the strokeend position 153528. The I-beam 153514 is shown at one example locationof a stroke begin position 153527. The I-beam 153514 firing memberstroke chart 153529 illustrates five firing member stroke regions153517, 153519, 153521, 153523, 153525. In a first firing stroke region153517, the I-beam 153514 may begin to advance distally. In the firstfiring stroke region 153517, the I-beam 153514 may contact the wedgesled 153513 and begin to move it distally. While in the first region,however, the cutting edge 153509 may not contact tissue and the wedgesled 153513 may not contact a staple driver 153511. After staticfriction is overcome, the force to drive the I-beam 153514 in the firstregion 153517 may be substantially constant.

In the second firing member stroke region 153519, the cutting edge153509 may begin to contact and cut tissue 153526. Also, the wedge sled153513 may begin to contact staple drivers 153511 to drive staples153505. Force to drive the I-beam 153514 may begin to ramp up. As shown,tissue encountered initially may be compressed and/or thinner because ofthe way that the anvil 153516 pivots relative to the staple cartridge153518. In the third firing member stroke region 153521, the cuttingedge 153509 may continuously contact and cut tissue 153526 and the wedgesled 153513 may repeatedly contact staple drivers 153511. Force to drivethe I-beam 153514 may plateau in the third region 153521. By the fourthfiring stroke region 153523, force to drive the I-beam 153514 may beginto decline. For example, tissue in the portion of the end effector153502 corresponding to the fourth firing region 153523 may be lesscompressed than tissue closer to the pivot point of the anvil 153516,requiring less force to cut. Also, the cutting edge 153509 and wedgesled 153513 may reach the end of the tissue 153526 while in the fourthregion 153523. When the I-beam 153514 reaches the fifth region 153525,the tissue 153526 may be completely severed. The wedge sled 153513 maycontact one or more staple drivers 153511 at or near the end of thetissue. Force to advance the I-beam 153514 through the fifth region153525 may be reduced and, in some examples, may be similar to the forceto drive the I-beam 153514 in the first region 153517. At the conclusionof the firing member stroke, the I-beam 153514 may reach the stroke endposition 153528. The positioning of firing member stroke regions 153517,153519, 153521, 153523, 153525 in FIG. 82 is just one example. In someexamples, different regions may begin at different positions along theend effector longitudinal axis 153515, for example, based on thepositioning of tissue between the anvil 153516 and the staple cartridge153518.

As discussed above and with reference now to FIGS. 80 to 82, theelectric motor 153120 positioned within a master controller of thesurgical instrument and can be utilized to advance and/or retract thefiring system of the shaft assembly, including the I-beam 153514,relative to the end effector 153502 of the shaft assembly in order tostaple and/or incise tissue captured within the end effector 153502. TheI-beam 153514 may be advanced or retracted at a desired speed, or withina range of desired speeds. The controller 153110 may be configured tocontrol the speed of the I-beam 153514. The controller 153110 may beconfigured to predict the speed of the I-beam 153514 based on variousparameters of the power supplied to the electric motor 153120, such asvoltage and/or current, for example, and/or other operating parametersof the electric motor 153120 or external influences. The controller153110 may be configured to predict the current speed of the I-beam153514 based on the previous values of the current and/or voltagesupplied to the electric motor 153120, and/or previous states of thesystem like velocity, acceleration, and/or position. The controller153110 may be configured to sense the speed of the I-beam 153514utilizing the absolute positioning sensor system described herein. Thecontroller can be configured to compare the predicted speed of theI-beam 153514 and the sensed speed of the I-beam 153514 to determinewhether the power to the electric motor 153120 should be increased inorder to increase the speed of the I-beam 153514 and/or decreased inorder to decrease the speed of the I-beam 153514.

Force acting on the I-beam 153514 may be determined using varioustechniques. The I-beam 153514 force may be determined by measuring themotor 153120 current, where the motor 153120 current is based on theload experienced by the I-beam 153514 as it advances distally. TheI-beam 153514 force may be determined by positioning a strain gauge onthe drive member, the firing member, I-beam 153514, the firing bar,and/or on a proximal end of the cutting edge 153509. The I-beam 153514force may be determined by monitoring the actual position of the I-beam153514 moving at an expected velocity based on the current set velocityof the motor 153120 after a predetermined elapsed period T₁ andcomparing the actual position of the I-beam 153514 relative to theexpected position of the I-beam 153514 based on the current set velocityof the motor 153120 at the end of the period T₁. Thus, if the actualposition of the I-beam 153514 is less than the expected position of theI-beam 153514, the force on the I-beam 153514 is greater than a nominalforce. Conversely, if the actual position of the I-beam 153514 isgreater than the expected position of the I-beam 153514, the force onthe I-beam 153514 is less than the nominal force. The difference betweenthe actual and expected positions of the I-beam 153514 is proportionalto the deviation of the force on the I-beam 153514 from the nominalforce.

Prior to turning to a description of closed loop control techniques ofthe closure tube and firing member, the description turns briefly toFIG. 83. FIG. 83 is a graph 153600 depicting two closure force (FTC)plots 153606, 153608 depicting the force applied to a closure member toclose on thick and thin tissue during a closure phase and a graph 153601depicting two firing force (FTF) plots 153622, 153624 depicting theforce applied to a firing member to fire through thick and thin tissueduring a firing phase. Referring to FIG. 83, the graph 153600 depicts anexample of the force applied to thick and thin tissue during a closurestroke to close the end effector 153502 relative to tissue graspedbetween the anvil 153516 and the staple cartridge 153518, where theclosure force is plotted as a function of time. The closure force plots153606, 153608 are plotted on two axes. A vertical axis 153602 indicatesthe closure force (FTC) the end effector 153502 in Newtons (N). Ahorizontal axis 153604 indicates time in seconds and labeled t₀ to t₁₃for clarity of description. The first closure force plot 153606 is anexample of the force applied to thick tissue during a closure stroke toclose the end effector 153502 relative to tissue grasped between theanvil 153516 and the staple cartridge 153518 and a second plot 153608 isan example of the force applied to thin tissue during a closure stroketo close the end effector 153502 relative to tissue grasped between theanvil 153516 and the staple cartridge 153518. The first and secondclosure force plots 153606, 153608 are divided into three phases, aclose stroke (CLOSE), a waiting period (WAIT), and a firing stroke(FIRE). During the closure stroke, a closure tube is translated distally(direction “DD”) to move the anvil 153516, for example, relative to thestaple cartridge 153518 in response to the actuation of the closurestroke by a closure motor. In other instances, the closure strokeinvolves moving the staple cartridge 153518 relative to an anvil 153516in response to the actuation of the closure motor and in other instancesthe closure stroke involves moving the staple cartridge 153518 and theanvil 153516 in response to the actuation of the closure motor. Withreference to the first closure force plot 153606, during the closurestroke the closure force 153610 increases from 0 up to a maximum forceF₁ from time t₀ to t₁. With reference to the second closure force graph153608, during the closure stroke the closure force 153616 increasesfrom 0 up to a maximum force F₃ from time t₀ to t₁. The relativedifference between the maximum forces F₁ and F₃ is due to the differencein closure force necessary for thick tissue relative to thin tissue,where greater force is required to close the anvil onto thick tissueversus thin tissue.

The first and second closure force plots 153606, 153608 indicate thatthe closure force in the end effector 153502 increases during an initialclamping time period ending at a time (t₁). The closure force reaches amaximum force (F₁, F₃) at the time (t₁). The initial clamping timeperiod can be about one second, for example. A waiting period can beapplied prior to initiating a firing stroke. The waiting period allowsfluid egress from tissue compressed by the end effector 153502, whichreduces the thickness of the compressed tissue yielding a smaller gapbetween the anvil 153516 and the staple cartridge 153518 and a reducedclosure force at the end of the waiting period. With reference to thefirst closure force plot 153606, there is a nominal drop in closureforce 153612 from F₁ to F₂ during the waiting period between t₁ to t₄.Similarly, with reference to the second closure force plot 153608, theclosure force 153618 drops nominally from F₃ to F₄ during the waitingperiod between t₁ to t₄. In some examples, a waiting period (t₁ to t₄)selected from a range of about 10 seconds to about 20 seconds istypically employed. In the example first and second closure force plots153606, 153608, a period of time of about 15 seconds is employed. Thewaiting period is followed by the firing stroke, which typically lasts aperiod of time selected from a range of about 3 seconds, for example, toabout 5 seconds, for example. The closure force decreases as the I-beam153514 is advanced relative to the end effector through the firingstroke. As indicated by the closure force 153614, 153620 of the firstand second closure force plots 153606, 153608, respectively, the closureforce 153614, 153620 exerted on the closure tube drops precipitouslyfrom about time t₄ to about time t₅. Time t₄ represents the moment wherethe I-beam 153514 couples into the anvil 153516 and begins to take overthe closing load. Accordingly, the closure force decreases as the firingforce increases as shown by the first and second firing force plots153622, 153624.

FIG. 83 also depicts a graph 153601 of first and second firing forceplots 153622, 153624 that plot the force applied to advance the I-beam153514 during the firing stroke of a surgical instrument or system inaccordance with the present disclosure. The firing force plots 153622,153624 are plotted on two axes. A vertical axis 153626 indicates thefiring force, in Newtons (N), applied to advance the I-beam 153514during the firing stroke. The I-beam 153514 is configured to advance aknife or cutting element and motivate drivers to deploy staples duringthe firing stroke. A horizontal axis 153605 indicates the time inseconds on the same time scale as the horizontal axis 153604 of theupper graph 153600.

As previously described, the closure tube force drops precipitously fromtime t₄ to about time t₅, which represents the moment the I-beam 153514couples into the anvil 153516 and begins to take load and the closureforce decreases as the firing force increases as shown by the first andsecond firing force plots 153622, 153624. The I-beam 153514 is advancedfrom the stroke begin position at time t₄ to the stroke end positionsbetween t₈ and t₉ for the firing force plot 153624 for thin tissue andat t₁₃ for the firing force plot 153622 for thick tissue. As the I-beam153514 is advanced distally during the firing stroke, the closureassembly surrenders control of the staple cartridge 153518 and the anvil153516 to the firing assembly, which causes the firing force to increaseand the closure force to decrease.

In the thick tissue firing force plot 153622, during the firing period(FIRE) the plot 153622 is divided into three distinct segments. A firstsegment 153628 indicates the firing force as it increases from 0 at t₄to a peak force F₁′ just prior to t₅. The first segment 153628 is thefiring force during the initial phase of the firing stroke where theI-beam 153514 advances distally from the top of the closure ramp untilthe I-beam 153514 contacts tissue. A second segment 153630 indicates thefiring force during a second phase of the firing stroke where the I-beam153514 is advancing distally deploying staples and cutting the tissue.During the second phase of the firing stroke the firing force drops fromF₁′ to F₂′ at about t₁₂. A third segment 153632 indicates the firingforce during the third and final phase of the firing stroke where theI-beam 153514 leaves the tissue and advances to the end of stroke in atissue free zone. During the third phase of the firing stroke the firingforce drops to from F₂′ to zero (0) at about t₁₃ where the I-beam 153514reaches the end of stroke. In summary, during the firing stroke, thefiring force rises dramatically as the I-beam 153514 enters a tissuezone, decrease steadily in the tissue zone during the stapling andcutting operation, and drops dramatically as the I-beam 153514 exits thetissue zone and enters a tissue free zone at the end of stroke.

The thin tissue firing force plot 153624 follows a similar pattern asthe thick tissue firing force plot 153622. Thus, during the first phaseof the firing stroke the firing force 153634 increases dramatically from0 to F₃′ at about t₅. During the second phase of the firing stroke, thefiring force 153636 drops steadily from F₃′ to F₄′ at about t₈. Duringthe final phase of the firing stroke the firing force 153638 dropsdramatically from F′₄ to 0 between t₈ and t₉.

To overcome the precipitous drop in closure force from time t₄ to abouttime t₅, which represents the moment the I-beam 153514 couples into theanvil 153516 and begins to take load and the closure force decreases asthe firing force increases, as shown by the first and second firingforce plots 153622, 153624, the closure tube may be advanced distallywhile the firing member such as the I-beam 153514 is advancing distally.The closure tube is represented as a transmission element that applies aclosure force to the anvil 153516. As described herein, a controlcircuit applies motor set points to the motor control which applies amotor control signal to the motor to drive the transmission element andadvance the closure tube distally to apply a closing force to the anvil153516. A torque sensor coupled to an output shaft of the motor can beused to measure the force applied to the closure tube. In other aspects,the closure force can be measured with a strain gauge, load cell, orother suitable force sensor.

FIG. 84 is a diagram of a control system 153950 configured to provideprogressive closure of a closure member (e.g., a closure tube) when thefiring member (e.g., I-beam 153514) advances distally and couples into aclamp arm (e.g., anvil 153516) to lower the closure force load on theclosure member at a desired rate and decrease the firing force load onthe firing member, in accordance with at least one aspect of thisdisclosure. In one aspect, the control system 153950 may be implementedas a nested PID feedback controller. A PID controller is a control loopfeedback mechanism (controller) to continuously calculate an error valueas the difference between a desired set point and a measured processvariable and applies a correction based on proportional, integral, andderivative terms (sometimes denoted P, I, and D respectively). Thenested PID controller feedback control system 153950 includes a primarycontroller 153952, in a primary (outer) feedback loop 153954 and asecondary controller 153955 in a secondary (inner) feedback loop 153956.The primary controller 153952 may be a PID controller 153972 as shown inFIG. 84, and the secondary controller 153955 also may be a PIDcontroller 153972 as shown in FIG. 85. The primary controller 153952controls a primary process 153958 and the secondary controller 153955controls a secondary process 153960. The output 153966 of the primaryprocess 153958 (OUTPUT) is subtracted from a primary set point SP₁ by afirst summer 153962. The first summer 153962 produces a single sumoutput signal which is applied to the primary controller 153952. Theoutput of the primary controller 153952 is the secondary set point SP₂.The output 153968 of the secondary process 153960 is subtracted from thesecondary set point SP₂ by a second summer 153964.

In the context of controlling the displacement of the closure tube, thecontrol system 153950 may be configured such that the primary set pointSP₁ is a desired closure force value and the primary controller 153952is configured to receive the closure force from the torque sensorcoupled to the output of the closure motor and determine a set point SP₂motor velocity for the closure motor. In other aspects, the closureforce may be measured with strain gauges, load cells, or other suitableforce sensors. The closure motor velocity set point SP₂ is compared tothe actual velocity of the closure tube, which is determined by thesecondary controller 153955. The actual velocity of the closure tube maybe measured by comparing the displacement of the closure tube with theposition sensor and measuring elapsed time with the timer/counter. Othertechniques, such as linear or rotary encoders may be employed to measuredisplacement of the closure tube. The output 153968 of the secondaryprocess 153960 is the actual velocity of the closure tube. This closuretube velocity output 153968 is provided to the primary process 153958which determines the force acting on the closure tube and is fed back tothe adder 153962, which subtracts the measured closure force from theprimary set point SP₁. The primary set point SP₁ may be an upperthreshold or a lower threshold. Based on the output of the adder 153962,the primary controller 153952 controls the velocity and direction of theclosure tube motor as described herein. The secondary controller 153955controls the velocity of the closure motor based on the actual velocityof closure tube measured by the secondary process 153960 and thesecondary set point SP₂, which is based on a comparison of the actualfiring force and the firing force upper and lower thresholds.

FIG. 85 illustrates a PID feedback control system 153970, in accordancewith at least one aspect of this disclosure. The primary controller153952 or the secondary controller 153955, or both, may be implementedas a PID controller 153972. In one aspect, the PID controller 153972 maycomprise a proportional element 153974 (P), an integral element 153976(I), and a derivative element 153978 (D). The outputs of the P, I, Delements 153974, 153976, 153978 are summed by a summer 153986, whichprovides the control variable u(t) to the process 153980. The output ofthe process 153980 is the process variable y(t). The summer 153984calculates the difference between a desired set point r(t) and ameasured process variable y(t). The PID controller 153972 continuouslycalculates an error value e(t) (e.g., difference between closure forcethreshold and measured closure force) as the difference between adesired set point r(t) (e.g., closure force threshold) and a measuredprocess variable y(t) (e.g., velocity and direction of closure tube) andapplies a correction based on the proportional, integral, and derivativeterms calculated by the proportional element 153974 (P), integralelement 153976 (I), and derivative element 153978 (D), respectively. ThePID controller 153972 attempts to minimize the error e(t) over time byadjustment of the control variable u(t) (e.g., velocity and direction ofthe closure tube).

In accordance with the PID algorithm, the “P” element 153974 accountsfor present values of the error. For example, if the error is large andpositive, the control output will also be large and positive. Inaccordance with the present disclosure, the error term e(t) is thedifferent between the desired closure force and the measured closureforce of the closure tube. The “I” element 153976 accounts for pastvalues of the error. For example, if the current output is notsufficiently strong, the integral of the error will accumulate overtime, and the controller will respond by applying a stronger action. The“D” element 153978 accounts for possible future trends of the error,based on its current rate of change. For example, continuing the Pexample above, when the large positive control output succeeds inbringing the error closer to zero, it also puts the process on a path tolarge negative error in the near future. In this case, the derivativeturns negative and the D module reduces the strength of the action toprevent this overshoot.

It will be appreciated that other variables and set points may bemonitored and controlled in accordance with the feedback control systems153950, 153970. For example, the adaptive closure member velocitycontrol algorithm described herein may measure at least two of thefollowing parameters: firing member stroke location, firing member load,displacement of cutting element, velocity of cutting element, closuretube stroke location, closure tube load, among others.

FIG. 86 is a logic flow diagram depicting a process 153990 of a controlprogram or a logic configuration for determining the velocity of aclosure member, in accordance with at least one aspect of thisdisclosure. A control circuit of a surgical instrument or system inaccordance with the present disclosure is configured to determine 153992the actual closure force of a closure member. The control circuitcompares 153994 the actual closure force to a threshold closure forceand determines 153996 a set point velocity to displace the closuremember based on the comparison. The control circuit controls 153998 theactual velocity of the closure member based on the set point velocity.

With reference now also to FIGS. 84 and 85, in one aspect, the controlcircuit comprises a proportional, integral, and derivative (PID)feedback control system 153950, 153970. The PID feedback control system153950, 153970 comprises a primary PID feedback loop 153954 and asecondary PID feedback loop 153956. The primary feedback loop 153954determines a first error between the actual closure force of the closuremember and a threshold closure force SP₁ and sets the closure membervelocity set point SP₂ based on the first error. The secondary feedbackloop 153956 determines a second error between the actual velocity of theclosure member and the set point velocity of the closure member an setsthe closure member velocity based on the second error.

In one aspect, the threshold closure force SP₁ comprises an upperthreshold and a lower threshold. The set point velocity SP₂ isconfigured to advance the closure member distally when the actualclosure force is less than the lower threshold and the set pointvelocity is configured to retract the closure member proximally when theactual closure force is greater than the lower threshold. In one aspect,the set point velocity is configured to hold the closure member in placewhen the actual closure force is between the upper and lower thresholds.

In one aspect, the control system further comprises a force sensor(e.g., any of sensors 472, 474, 476 (FIG. 12), for example) coupled tothe control circuit. The force sensor is configured measure the closureforce. In one aspect, the force sensor comprises a torque sensor coupledto an output shaft of a motor coupled to the closure member. In oneaspect, the force sensor comprises a strain gauge coupled to the closuremember. In one aspect, the force sensor comprises a load cell coupled tothe closure member. In one aspect, the control system comprises aposition sensor coupled to the closure member, wherein the positionsensor is configured to measure the position of the closure member.

In one aspect, the control system comprises a first motor configured tocouple to the closure member and the control circuit is configured toadvance the closure member during at least a portion of a firing stroke.

The functions or processes 153990 described herein may be executed byany of the processing circuits described herein. Aspects of themotorized surgical instrument may be practiced without the specificdetails disclosed herein. Some aspects have been shown as block diagramsrather than detail.

Parts of this disclosure may be presented in terms of instructions thatoperate on data stored in a computer memory. An algorithm refers to aself-consistent sequence of steps leading to a desired result, where a“step” refers to a manipulation of physical quantities which may takethe form of electrical or magnetic signals capable of being stored,transferred, combined, compared, and otherwise manipulated. Thesesignals may be referred to as bits, values, elements, symbols,characters, terms, numbers. These and similar terms may be associatedwith the appropriate physical quantities and are merely convenientlabels applied to these quantities.

Generally, aspects described herein which can be implemented,individually and/or collectively, by a wide range of hardware, software,firmware, or any combination thereof can be viewed as being composed ofvarious types of “electrical circuitry.” Consequently, “electricalcircuitry” includes electrical circuitry having at least one discreteelectrical circuit, electrical circuitry having at least one integratedcircuit, electrical circuitry having at least one application specificintegrated circuit, electrical circuitry forming a general purposecomputing device configured by a computer program (e.g., a generalpurpose computer or processor configured by a computer program which atleast partially carries out processes and/or devices described herein,electrical circuitry forming a memory device (e.g., forms of randomaccess memory), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, or optical-electricalequipment). These aspects may be implemented in analog or digital form,or combinations thereof.

The foregoing description has set forth aspects of devices and/orprocesses via the use of block diagrams, flowcharts, and/or examples,which may contain one or more functions and/or operation. Each functionand/or operation within such block diagrams, flowcharts, or examples canbe implemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof. Inone aspect, several portions of the subject matter described herein maybe implemented via Application Specific Integrated Circuits (ASICs),Field Programmable Gate Arrays (FPGAs), digital signal processors(DSPs), Programmable Logic Devices (PLDs), circuits, registers and/orsoftware components, e.g., programs, subroutines, logic and/orcombinations of hardware and software components. Logic gates, or otherintegrated formats. Some aspects disclosed herein, in whole or in part,can be equivalently implemented in integrated circuits, as one or morecomputer programs running on one or more computers (e.g., as one or moreprograms running on one or more computer systems), as one or moreprograms running on one or more processors (e.g., as one or moreprograms running on one or more microprocessors), as firmware, or asvirtually any combination thereof, and that designing the circuitryand/or writing the code for the software and or firmware would be wellwithin the skill of one of skill in the art in light of this disclosure.

The mechanisms of the disclosed subject matter are capable of beingdistributed as a program product in a variety of forms, and that anillustrative aspect of the subject matter described herein appliesregardless of the particular type of signal bearing medium used toactually carry out the distribution. Examples of a signal bearing mediuminclude the following: a recordable type medium such as a floppy disk, ahard disk drive, a Compact Disc (CD), a Digital Video Disk (DVD), adigital tape, a computer memory, etc.; and a transmission type mediumsuch as a digital and/or an analog communication medium (e.g., a fiberoptic cable, a waveguide, a wired communications link, a wirelesscommunication link (e.g., transmitter, receiver, transmission logic,reception logic, etc.).

The foregoing description of these aspects has been presented forpurposes of illustration and description. It is not intended to beexhaustive or limiting to the precise form disclosed. Modifications orvariations are possible in light of the above teachings. These aspectswere chosen and described in order to illustrate principles andpractical application to thereby enable one of ordinary skill in the artto utilize the aspects and with modifications as are suited to theparticular use contemplated. It is intended that the claims submittedherewith define the overall scope.

Situational Awareness

Situational awareness is the ability of some aspects of a surgicalsystem to determine or infer information related to a surgical procedurefrom data received from databases and/or instruments. The informationcan include the type of procedure being undertaken, the type of tissuebeing operated on, or the body cavity that is the subject of theprocedure. With the contextual information related to the surgicalprocedure, the surgical system can, for example, improve the manner inwhich it controls the modular devices (e.g. a robotic arm and/or roboticsurgical tool) that are connected to it and provide contextualizedinformation or suggestions to the surgeon during the course of thesurgical procedure.

Referring now to FIG. 87, a timeline 5200 depicting situationalawareness of a hub, such as the surgical hub 106 or 206, for example, isdepicted. The timeline 5200 is an illustrative surgical procedure andthe contextual information that the surgical hub 106, 206 can derivefrom the data received from the data sources at each step in thesurgical procedure. The timeline 5200 depicts the typical steps thatwould be taken by the nurses, surgeons, and other medical personnelduring the course of a lung segmentectomy procedure, beginning withsetting up the operating theater and ending with transferring thepatient to a post-operative recovery room.

The situationally aware surgical hub 106, 206 receives data from thedata sources throughout the course of the surgical procedure, includingdata generated each time medical personnel utilize a modular device thatis paired with the surgical hub 106, 206. The surgical hub 106, 206 canreceive this data from the paired modular devices and other data sourcesand continually derive inferences (i.e., contextual information) aboutthe ongoing procedure as new data is received, such as which step of theprocedure is being performed at any given time. The situationalawareness system of the surgical hub 106, 206 is able to, for example,record data pertaining to the procedure for generating reports, verifythe steps being taken by the medical personnel, provide data or prompts(e.g., via a display screen) that may be pertinent for the particularprocedural step, adjust modular devices based on the context (e.g.,activate monitors, adjust the field of view (FOV) of the medical imagingdevice, or change the energy level of an ultrasonic surgical instrumentor RF electrosurgical instrument), and take any other such actiondescribed above.

As the first step 5202 in this illustrative procedure, the hospitalstaff members retrieve the patient's EMR from the hospital's EMRdatabase. Based on select patient data in the EMR, the surgical hub 106,206 determines that the procedure to be performed is a thoracicprocedure.

Second step 5204, the staff members scan the incoming medical suppliesfor the procedure. The surgical hub 106, 206 cross-references thescanned supplies with a list of supplies that are utilized in varioustypes of procedures and confirms that the mix of supplies corresponds toa thoracic procedure. Further, the surgical hub 106, 206 is also able todetermine that the procedure is not a wedge procedure (because theincoming supplies either lack certain supplies that are necessary for athoracic wedge procedure or do not otherwise correspond to a thoracicwedge procedure).

Third step 5206, the medical personnel scan the patient band via ascanner that is communicably connected to the surgical hub 106, 206. Thesurgical hub 106, 206 can then confirm the patient's identity based onthe scanned data.

Fourth step 5208, the medical staff turns on the auxiliary equipment.The auxiliary equipment being utilized can vary according to the type ofsurgical procedure and the techniques to be used by the surgeon, but inthis illustrative case they include a smoke evacuator, insufflator, andmedical imaging device. When activated, the auxiliary equipment that aremodular devices can automatically pair with the surgical hub 106, 206that is located within a particular vicinity of the modular devices aspart of their initialization process. The surgical hub 106, 206 can thenderive contextual information about the surgical procedure by detectingthe types of modular devices that pair with it during this pre-operativeor initialization phase. In this particular example, the surgical hub106, 206 determines that the surgical procedure is a VATS procedurebased on this particular combination of paired modular devices. Based onthe combination of the data from the patient's EMR, the list of medicalsupplies to be used in the procedure, and the type of modular devicesthat connect to the hub, the surgical hub 106, 206 can generally inferthe specific procedure that the surgical team will be performing. Oncethe surgical hub 106, 206 knows what specific procedure is beingperformed, the surgical hub 106, 206 can then retrieve the steps of thatprocedure from a memory or from the cloud and then cross-reference thedata it subsequently receives from the connected data sources (e.g.,modular devices and patient monitoring devices) to infer what step ofthe surgical procedure the surgical team is performing.

Fifth step 5210, the staff members attach the EKG electrodes and otherpatient monitoring devices to the patient. The EKG electrodes and otherpatient monitoring devices are able to pair with the surgical hub 106,206. As the surgical hub 106, 206 begins receiving data from the patientmonitoring devices, the surgical hub 106, 206 thus confirms that thepatient is in the operating theater.

Sixth step 5212, the medical personnel induce anesthesia in the patient.The surgical hub 106, 206 can infer that the patient is under anesthesiabased on data from the modular devices and/or patient monitoringdevices, including EKG data, blood pressure data, ventilator data, orcombinations thereof, for example. Upon completion of the sixth step5212, the pre-operative portion of the lung segmentectomy procedure iscompleted and the operative portion begins.

Seventh step 5214, the patient's lung that is being operated on iscollapsed (while ventilation is switched to the contralateral lung). Thesurgical hub 106, 206 can infer from the ventilator data that thepatient's lung has been collapsed, for example. The surgical hub 106,206 can infer that the operative portion of the procedure has commencedas it can compare the detection of the patient's lung collapsing to theexpected steps of the procedure (which can be accessed or retrievedpreviously) and thereby determine that collapsing the lung is the firstoperative step in this particular procedure.

Eighth step 5216, the medical imaging device (e.g., a scope) is insertedand video from the medical imaging device is initiated. The surgical hub106, 206 receives the medical imaging device data (i.e., video or imagedata) through its connection to the medical imaging device. Upon receiptof the medical imaging device data, the surgical hub 106, 206 candetermine that the laparoscopic portion of the surgical procedure hascommenced. Further, the surgical hub 106, 206 can determine that theparticular procedure being performed is a segmentectomy, as opposed to alobectomy (note that a wedge procedure has already been discounted bythe surgical hub 106, 206 based on data received at the second step 5204of the procedure). The data from the medical imaging device 124 (FIG. 2)can be utilized to determine contextual information regarding the typeof procedure being performed in a number of different ways, including bydetermining the angle at which the medical imaging device is orientedwith respect to the visualization of the patient's anatomy, monitoringthe number or medical imaging devices being utilized (i.e., that areactivated and paired with the surgical hub 106, 206), and monitoring thetypes of visualization devices utilized. For example, one technique forperforming a VATS lobectomy places the camera in the lower anteriorcorner of the patient's chest cavity above the diaphragm, whereas onetechnique for performing a VATS segmentectomy places the camera in ananterior intercostal position relative to the segmental fissure. Usingpattern recognition or machine learning techniques, for example, thesituational awareness system can be trained to recognize the positioningof the medical imaging device according to the visualization of thepatient's anatomy. As another example, one technique for performing aVATS lobectomy utilizes a single medical imaging device, whereas anothertechnique for performing a VATS segmentectomy utilizes multiple cameras.As yet another example, one technique for performing a VATSsegmentectomy utilizes an infrared light source (which can becommunicably coupled to the surgical hub as part of the visualizationsystem) to visualize the segmental fissure, which is not utilized in aVATS lobectomy. By tracking any or all of this data from the medicalimaging device, the surgical hub 106, 206 can thereby determine thespecific type of surgical procedure being performed and/or the techniquebeing used for a particular type of surgical procedure.

Ninth step 5218, the surgical team begins the dissection step of theprocedure. The surgical hub 106, 206 can infer that the surgeon is inthe process of dissecting to mobilize the patient's lung because itreceives data from the RF or ultrasonic generator indicating that anenergy instrument is being fired. The surgical hub 106, 206 cancross-reference the received data with the retrieved steps of thesurgical procedure to determine that an energy instrument being fired atthis point in the process (i.e., after the completion of the previouslydiscussed steps of the procedure) corresponds to the dissection step. Incertain instances, the energy instrument can be an energy tool mountedto a robotic arm of a robotic surgical system.

Tenth step 5220, the surgical team proceeds to the ligation step of theprocedure. The surgical hub 106, 206 can infer that the surgeon isligating arteries and veins because it receives data from the surgicalstapling and cutting instrument indicating that the instrument is beingfired. Similarly to the prior step, the surgical hub 106, 206 can derivethis inference by cross-referencing the receipt of data from thesurgical stapling and cutting instrument with the retrieved steps in theprocess. In certain instances, the surgical instrument can be a surgicaltool mounted to a robotic arm of a robotic surgical system.

Eleventh step 5222, the segmentectomy portion of the procedure isperformed. The surgical hub 106, 206 can infer that the surgeon istransecting the parenchyma based on data from the surgical stapling andcutting instrument, including data from its cartridge. The cartridgedata can correspond to the size or type of staple being fired by theinstrument, for example. As different types of staples are utilized fordifferent types of tissues, the cartridge data can thus indicate thetype of tissue being stapled and/or transected. In this case, the typeof staple being fired is utilized for parenchyma (or other similartissue types), which allows the surgical hub 106, 206 to infer that thesegmentectomy portion of the procedure is being performed.

Twelfth step 5224, the node dissection step is then performed. Thesurgical hub 106, 206 can infer that the surgical team is dissecting thenode and performing a leak test based on data received from thegenerator indicating that an RF or ultrasonic instrument is being fired.For this particular procedure, an RF or ultrasonic instrument beingutilized after parenchyma was transected corresponds to the nodedissection step, which allows the surgical hub 106, 206 to make thisinference. It should be noted that surgeons regularly switch back andforth between surgical stapling/cutting instruments and surgical energy(i.e., RF or ultrasonic) instruments depending upon the particular stepin the procedure because different instruments are better adapted forparticular tasks. Therefore, the particular sequence in which thestapling/cutting instruments and surgical energy instruments are usedcan indicate what step of the procedure the surgeon is performing.Moreover, in certain instances, robotic tools can be utilized for one ormore steps in a surgical procedure and/or handheld surgical instrumentscan be utilized for one or more steps in the surgical procedure. Thesurgeon(s) can alternate between robotic tools and handheld surgicalinstruments and/or can use the devices concurrently, for example. Uponcompletion of the twelfth step 5224, the incisions are closed up and thepost-operative portion of the procedure begins.

Thirteenth step 5226, the patient's anesthesia is reversed. The surgicalhub 106, 206 can infer that the patient is emerging from the anesthesiabased on the ventilator data (i.e., the patient's breathing rate beginsincreasing), for example.

Lastly, the fourteenth step 5228 is that the medical personnel removethe various patient monitoring devices from the patient. The surgicalhub 106, 206 can thus infer that the patient is being transferred to arecovery room when the hub loses EKG, BP, and other data from thepatient monitoring devices. As can be seen from the description of thisillustrative procedure, the surgical hub 106, 206 can determine or inferwhen each step of a given surgical procedure is taking place accordingto data received from the various data sources that are communicablycoupled to the surgical hub 106, 206.

Situational awareness is further described in U.S. Provisional PatentApplication Ser. No. 62/611,341, titled INTERACTIVE SURGICAL PLATFORM,filed Dec. 28, 2017, which is incorporated by reference herein in itsentirety. In certain instances, operation of a robotic surgical system,including the various robotic surgical systems disclosed herein, forexample, can be controlled by the hub 106, 206 based on its situationalawareness and/or feedback from the components thereof and/or based oninformation from the cloud 104.

Irregularities in Tissue Distribution

Typically, in a surgical stapling procedure, a user places the jaws ofthe end effector around tissue to clamp and staple the tissue. In someinstances, the majority of the tissue clamped between the jaws of thesurgical stapling instrument can be concentrated in a portion of the gapbetween the jaws while the remainder of the gap remains unoccupied orslightly occupied. Irregularities in distribution of tissue positionedbetween the jaws of a surgical stapling instrument can reduce staplingoutcome consistency. For example, the irregular tissue distribution canlead to excessive tissue compression in parts of the clamped tissue, andinsufficient tissue compression in other parts of the clamped tissue,which may have a negative impact on the tissue being operated on. Forexample, excessive compression of tissue may result in tissue necrosisand, in certain procedures, staple line failure. Insufficient tissuecompression also negatively impacts staple deployment and formation, andmay cause the stapled tissue to leak or heal improperly.

Aspects of the present disclosure present a surgical stapling instrumentthat includes an end effector configured to staple tissue clampedbetween a first jaw and a second jaw of the end effector. The surgicalstapling instrument is configured to sense and indicate irregularitiesin tissue distribution with respect to a number of predetermined zonesbetween the first jaw and the second jaw, within the end effector. Thesurgical stapling instrument is further configured to sense and indicateirregularities in the amount and location of the tissue among thepredetermined zones.

In one aspect, the surgical stapling instrument is configured to providefeedback on the most appropriate location and positioning of tissue insituations where tissue irregularities are detected.

Absolute measurements of the tissue impedance at the predetermined zonesmay be significantly influenced by the environment in which the endeffector is immersed. For example, an end effector immersed in a fluidsuch as blood, for example, will yield different tissue impedancemeasurements than an end effector not immersed in blood. Also, an endeffector clamped around a previously stapled tissue will yield differenttissue impedance measurements than an end effector clamped aroundunstapled tissue. The present disclosure addresses such discrepancieswhen assessing tissue distribution in different predetermined zones byevaluating the tissue impedance measurements at the differentpredetermined zones in comparison to one another.

In one aspect, irregularities in the tissue clamped between the jaws ofthe surgical stapling instrument yield different tissue compressions atthe predetermined zones. Aspects of the present disclosure present asurgical stapling instrument including a tissue-distribution assessmentcircuit configured to sense and indicate irregularities in the tissuecompression among the predetermined zones by measuring impedance betweenthe jaws of the end effector at each of the predetermined zones.

In one aspect, the tissue-distribution assessment circuit of thesurgical stapling instrument comprises one or more tissue contactcircuits at each of the predetermined zones configured to measure tissueimpedance to assess position and amount of the clamped tissue.

For brevity, one or more of the embodiments of the present disclosureare described in connection with a specific type of surgicalinstruments. This should not be construed, however, as limiting. Theembodiments of the present disclosure are applicable to various types ofsurgical stapling instruments such as, for example, linear surgicalstapling instruments, curved surgical stapling instruments, and/orcircular stapling instruments. The embodiments of the present disclosureare also equally applicable to surgical instrument that appliestherapeutic energy to tissue such as, for example, ultrasonic or radiofrequency (RF) energy.

Referring to FIG. 88, an end effector 25002 extending from a shaft 25004of a curved surgical stapling instrument is depicted. The end effector25002 includes a first jaw 25006 defining an anvil 25007 and a secondjaw 25008 that includes a staple cartridge 25009. The staple cartridge25009 and the anvil 25007 have as an arc-like shape in thecross-sectional plane. The staple cartridge 25009 can be removed fromthe rest of the end effector 25002 and is mounted in a cartridge holderslidably mounted in a guide portion. An arm 250010 supporting the anvilis rigidly connected to one end of the guide portion and runs inparallel to a longitudinal axis L defined by the shaft 25004.

Tissue is clamped between the anvil 25007 and the staple cartridge 25009by moving the staple cartridge 25009 distally toward the anvil 25007. Incertain aspects, the anvil 25007 is moved proximally toward the staplecartridge 25009 to clamp the tissue therebetween. In other aspects, theanvil and the staple cartridge are moved relative to one another toclamp the tissue therebetween. As illustrated in FIG. 88, the anvil25007 and staple cartridge 25009 define a stapling plane perpendicularto the longitudinal axis L. Staples are deployed in curved rows from thestaple cartridge 25009 into tissue clamped between the staple cartridge25009 and the anvil 25007.

Referring again to FIG. 88, three tissue-distribution assessment zones(Zone 1, Zone 2, Zone 3) are defined along the curved length of theanvil 25007. Each of the three zones extends along a portion of thecurved length of the anvil 25007. Tissue impedance is measured at eachof the three zones to assess irregularities in tissue distributionbetween the anvil 25007 and the staple cartridge 25009. Zone 1, which isalso referred to herein as the crotch zone, is an inner zone residingclosest to the arm 25010 while zone 3 is an outer zone, and is fartheraway from the arm 25010 than Zone 1. Zone 2 is an intermediate zoneextending between Zone 1 and Zone 3. Zone 1 and Zone 3 each extend alongabout one quarter of the curved length of the anvil 25007. On the otherhand, Zone 2 extends along about one half of the curved length of theanvil between Zone 1 and Zone 3.

FIG. 89 is a partial cross-sectional view of the end effector of FIG. 88shown grasping tissue between its jaws at the three tissue-distributionassessment zones (Zone 1, Zone 2, Zone 3). FIG. 90 illustrates aperspective view of an end effector 25020 of a surgical stapling andcutting instrument including tissue-distribution assessment zones (Zone1, Zone 2, Zone 3), which are similar in many respects to thetissue-distribution assessment zones (Zone 1, Zone 2, Zone 3) of the endeffector 25002.

In the embodiment of FIG. 88, the anvil 25007 has a tissue contactingsurface 25012 that is divided into the three zones (Zone 1, Zone 2, Zone3). Tissue impedance measurements at the three zones represent tissuedistribution within the end effector 25002. In various aspects, thenumber of zones can be greater or less than three. In one example, asurgical stapling instrument may include four zones, as illustrated inFIG. 103. In another examples, a surgical stapling instrument mayinclude eight zones, as illustrated in FIG. 104. The size of the zonescan be the same, or at least substantially the same. Alternatively, thesize of the zones may vary, as illustrated in FIG. 88.

A suitable number, size, and location of the zones may be selecteddepending on the type of surgical instrument. For example, a linearsurgical stapling instrument may include an inner or proximal zone,which is closest to the shaft, an outer or distal zone, which isfarthest from the shaft, and one or more intermediate zones between theinner zone and the outer zone.

The three zones of the embodiment of FIG. 88 are defined with respect tothe tissue contacting surface 25012 of the anvil 25007. In otherembodiments, however, tissue-distribution assessment zones may bedefined with respect to a tissue contacting surface of a staplecartridge. In other words, the tissue contacting surface of the staplecartridge can be divided into predetermined zones for the purpose ofassessing tissue distribution within an end effector.

Each of the three zones of the embodiment of FIG. 88 includes one ormore tissue contact circuits that are configured to measure impedance ofa tissue portion residing at the predetermined zone. An example tissuecontacting circuit is illustrated in FIG. 24. Tissue “T” contact withthe anvil 25007 and staple cartridge 25009 at a predetermined zonecloses the sensing circuit “SC” at the predetermined zone, which isotherwise open, by simultaneously establishing contact with a pair ofopposed plates “P1, P2” provided on the anvil 25007 and staple cartridge25009 at the predetermined zone.

Any of the contact circuits disclosed herein may include, and are notlimited to, electrical contacts placed on an inner surface of a jawwhich, when in contact with tissue, close a sensing circuit that isotherwise open.

The contact circuits may also include sensitive force transducers thatdetermine the amount of force being applied to the sensor, which may beassumed to be the same amount of force being applied to the tissue “T”.Such force being applied to the tissue “T” may then be translated intoan amount of tissue compression. The force sensors measure the amount ofcompression a tissue “T” is under, and provide a surgeon withinformation about the force applied to the tissue “T”.

As described above, excessive tissue compression may have a negativeimpact on the tissue “T” being operated on. For example, excessivecompression of tissue “T” may result in tissue necrosis and, in certainprocedures, staple line failure. Information regarding the pressurebeing applied to tissue “T” enables a surgeon to better determine thatexcessive pressure is not being applied to tissue “T”.

The force transducers of the contact circuits may include, and are notlimited to, piezoelectric elements, piezoresistive elements, metal filmor semiconductor strain gauges, inductive pressure sensors, capacitivepressure sensors, and potentiometric pressure transducers that usebourbon tubes, capsules or bellows to drive a wiper arm on a resistiveelement.

In various aspects, the predetermined zones within an end effector 25002may comprise one or more segmented flexible circuit configured tofixedly attach to at least one jaw member of the end effector 25002.Examples of suitable segmented flexible circuits are described inconnection with FIG. 75 of the present disclosure. To measure tissueimpedances, the segmented flexible circuit pass sub-therapeuticelectrical signals through the tissue at each of the predeterminedzones.

FIGS. 91-96 illustrate three tissue distribution examples (T1, T2, T3)within an end effector 25002. Straightened cross-sectional views of theend effector 25002 in FIGS. 91-93 illustrate an initial distribution oftissue among the three zones (Zone 1, Zone 2, Zone 3) within the endeffector 25002 according to each of the three examples. Straightenedcross-sectional views of the end effector in FIGS. 94-96 illustrate thetissue of the three examples under an initial compression to close thesensing contact circuits between the tissue-contacting surfaces of theanvil 25007 and the staple cartridge 25009.

As described above, establishing contact between the tissue “T” and thetissue contacting surfaces of the anvil 25007 and the staple cartridge25009 at a predetermined zone closes a sensing circuit at thepredetermined zone. The closure of the sensing circuit causes a currentto pass through the tissue “T” at the predetermined zone, as illustratedin FIG. 89, and the sensing circuit. Impedance of the tissue “T” at thepredetermined zone can be calculated from the formula:

$Z_{tissue} = {\left( \frac{V}{I} \right) - Z_{{sense}\mspace{14mu} {circuit}}}$

wherein Z_(tissue) is tissue impedance, V is voltage, I is current, andZ_(sense circuit) is impedance of the sense circuit.

As illustrated in FIG. 89, insulating elements 25014 can be positionedbetween adjacent plates (p) to separate adjacent sensing circuits.Although three sensing circuits are represented in FIG. 89, the numberof sensing circuits can be different than three. In various examples, anend effector may include an “n” number of sensing circuits correspondingto an “n” number of predetermined zones, wherein “n” is an integergreater than or equal to the number 3.

FIG. 97 illustrates a logic flow diagram of a process 25030 depicting acontrol program or a logic configuration for identifying irregularitiesin tissue distribution within an end effector 25002 of a surgicalinstrument, in accordance with at least one aspect of the presentdisclosure. In one aspect, the process 25030 is executed by a controlcircuit 500 (FIG. 13). In another aspect, the process 25030 can beexecuted by a combinational logic circuit 510 (FIG. 14). In yet anotheraspect, the process 25030 can be executed by a sequential logic circuit520 (FIG. 15).

The process 25030 includes receiving 25032 sensor signals from sensorcircuits of a sensing circuit assembly 25471 corresponding topredetermined zones (e.g. zone 1, Zone 2, and Zone 3) within the endeffector 25002, determining 25034 tissue impedance Z_(tissue) of tissueportions at such zones based on the received sensor signals. FIG. 98illustrates tissue impedance Z_(tissue) curves 25001, 25003, 25005,which correspond to the tissue examples T1, T2, T3, respectively.

The process 25030 further includes conditional steps 25036, 25038. If itis determined that the average of the tissue impedances of an inner zone(e.g. Zone 1) and an outer zone (e.g. Zone 3) is greater than the tissueimpedance of the intermediate zone (e.g. Zone 2), then tissuedistribution is considered to be inadequate, instructions are providedfor releasing 25040 the grasped tissue and repositioning the endeffector 25002, as illustrated by the example in FIGS. 92, 95, 98, 100.In certain instances, during the release cycle the grasped tissue isonly released to a minimum threshold and then re-clamped so that thetissue does not slip out of the end effector 25002.

If, however, the average of the tissue impedances of an outer zone (e.g.Zone 1) and an inner zone (e.g. Zone 3) is less than or equal to thetissue impedance of an intermediate zone (e.g. Zone 2), and tissueimpedance of the inner zone is less than or equal to the tissueimpedance of the outer zone, then tissue distribution is considered tobe adequate, and the end effector closure is continued 25042 whilemaintaining a predetermined Force-To-Close (FTC) threshold rate, asillustrated by the example of FIGS. 91, 94, 98, 99.

If, however, the average of the tissue impedances of an outer zone (e.g.Zone 1) and an inner zone (e.g. Zone 3) is less than or equal to thetissue impedance of an intermediate zone (e.g. Zone 2), and tissueimpedance of the inner zone is greater than the tissue impedance of theouter zone, then tissue distribution is considered to be adequate, butthe FTC threshold rate is reduced 25044 to a slower rate, as illustratedby the example of FIGS. 93, 96, 98, 101.

FIG. 102 illustrates a logic diagram of a control system 25470, whichcan be employed to execute the process of FIG. 97. The control system25470 is similar in many respects to the control system 470 (FIG. 12).In addition, the control system 25470 includes a sensing circuitassembly 25471 that includes an “n” number of sensing circuits S₁-S_(n),wherein “n” is an integer greater than two. The sensing circuitsS₁-S_(n) define predetermined zones within an end effector, as describedabove.

In various examples, the sensing circuit assembly 25471 includes an “n”number of continuity sensors, wherein “n” is an integer greater thantwo. The continuity sensors define predetermined zones within an endeffector, as described above.

In various examples, sensing circuits S₁-S_(n) can be configured toprovide sensor signals indicative of tissue compression using impedancemeasurements. Continuity sensors S₁-S_(n) can be used to inform whethersufficient tissue extends within an end effector 25002. In addition, FTCsensors can be used in assessing tissue creep rates in order todetermine tissue distribution within an end effector 25002.

In various aspects, the sensing circuits S₁-S_(n) can be configured tomeasure tissue impedance by driving a sub-therapeutic RF current throughthe tissue grasped by an end effector 25002. One or more electrodes canbe positioned on either or both jaws of the end effector 25002. Thetissue compression/impedance of the grasped tissue can be measured overtime.

In various aspects, various sensors such as a magnetic field sensor, astrain gauge, a pressure sensor, a force sensor, an inductive sensorsuch as, for example, an eddy current sensor, a resistive sensor, acapacitive sensor, an optical sensor, and/or any other suitable sensor,may be adapted and configured to measure tissue compression/impedance atpredetermined zones within an end effector.

In various aspects, the rate of closure system advancement is changed bythe microcontroller 461 if more tissue is sensed in an inner zone thanan outer zone of an end effector 25002. The closure rate is slowed downto improve tissue distribution by allowing time for the tissue in theinner zone to creep outward within the end effector 25002.

In various aspects, monitoring the change in impedance as closure gapchanges may be used to inform tissue properties and positioning as well.

FIG. 99 illustrates a graph 25400 depicting end effector FTC 25402 andclosure velocity 25404 verse time 25406 for an illustrative firing of anend effector 25002 of a surgical instrument, in accordance with at leastone aspect of the present disclosure. In the following description ofthe graph 25400, reference should also be made to FIGS. 91, 94, 97. Theillustrative firings described herein are for the purpose ofdemonstrating the concepts discussed above with respect to FIGS. 91, 94,97 and should not be interpreted as limiting in any way.

A firing of the end effector 25002, as illustrated in FIGS. 91, 94, canbe represented by a FTC curve 25408 and a corresponding velocity curve25408′, which illustrate the change in FTC and closure velocity overtime during the course of the firing, respectively. The firing canrepresent, for example, a firing of the end effector 25002 of a surgicalinstrument that includes a control circuit executing the process 25030depicted in FIG. 97. As firing of the end effector 25002 is initiated,the processor 462 controls the motor 482 to begin driving the anvil25007 from its open position, causing the closure velocity of the anvil25007 to sharply increase 25416 until it plateaus 25418 at a particularclosure velocity. As the anvil 25007 closes, the FTC increases 25410until it peaks 25412 at a particular time. From the peak 25412, the FTCdecreases 25414 until the tissue “T1” is fully clamped, at which pointthe processor 462 controls the motor 482 to halt the closure of theanvil 25007 and the closure velocity drops 25420 to zero.

The firing of FIGS. 91, 94 thus represents a firing of the end effector25002 wherein tissue distribution between the jaws 25006, 25008 iswithin acceptable limits. In other words, the firing of FIGS. 91, 94stays within all control parameters during the course of the jawclosure. Thus, the processor 462 does not pause the anvil 25007, adjustthe closure velocity of the anvil 25007, or take any other correctiveaction during the course.

FIG. 14 illustrates a graph 25422 depicting end effector FTC 25402 andclosure velocity 25404 verse time 25406 for an illustrative firing of anend effector 25007 of a surgical instrument, in accordance with at leastone aspect of the present disclosure. In the following description ofthe graph 25422, reference should also be made to FIGS. 92, 95, 97. Theillustrative firings described herein are for the purpose ofdemonstrating the concepts discussed above with respect to FIGS. 92, 95,97 and should not be interpreted as limiting in any way.

A firing of the end effector 25002, as illustrated in FIGS. 92, 95, 97,can be represented by an FTC curve 25424 and a corresponding velocitycurve 25424′, which illustrate the change in FTC and closure velocityover time during the course of the firing, respectively. The firing ofFIGS. 92, 95 can represent, for example, a firing of an end effector25007 of a surgical instrument that includes a control circuit executingthe process 25030 depicted in FIG. 97. As firing of the end effector25007 is initiated, the processor 462 controls the motor 482 to begindriving the anvil 25007 from its open position, causing the closurevelocity of the anvil 25007 to sharply increase 25432 until it reaches aparticular closure velocity. As the anvil 25012 closes, the FTCincreases 25426 until it peaks 25428 at a particular time. In thisinstance, the processor 462 receives input from the sensing circuitassembly 25471 indicating that tissue distribution between the jaws25006, 2008 is skewed toward the third zone, as illustrated in FIGS. 92,95.

In response, as outlined in the process 25030, the processor 462instructs, through display 473, the operator of the end effector 25007of the surgical instrument to open the jaws 25006, 25008 in order toreadjust the tissue “T2” therein. Thus, the closure velocity drops 25434until it reaches a negative closure velocity, indicating that the jaws25006, 25008 are being opened in order to, for example, easily permitthe tissue “T2” to be readjusted within the jaws 25006, 25008. Theclosure velocity then returns 25436 back to zero, the jaws 25006, 25008stopped. Correspondingly, the FTC decreases 25430 to zero as the jaws25006, 25008 are released from the tissue “T2”.

FIG. 101 illustrates a graph 25438 depicting end effector FTC 25402 andclosure velocity 25404 verse time 25406 for an illustrative firing of asurgical instrument, in accordance with at least one aspect of thepresent disclosure. In the following description of the seventh graph25438, reference should also be made to FIGS. 93, 96, 97. Theillustrative firings described herein are for the purpose ofdemonstrating the concepts discussed above with respect to FIGS. 93, 96,97 and should not be interpreted as limiting in any way.

A firing of the end effector 25002, as illustrated in FIGS. 93, 96, 97can be represented by an FTC curve 21440 and a corresponding velocitycurve 25440′, which illustrate the change in FTC and closure velocityover time during the course of the firing, respectively. The firing ofFIGS. 93, 96 can represent, for example, an end effector 25002 of asurgical instrument that includes a control circuit executing theprocess 25030 depicted in FIG. 11. As firing of the end effector 25002is initiated, the processor 462 controls the motor 482 to begin drivingthe anvil 25007 from its open position, causing the closure velocity ofthe anvil 25007 to sharply increase 25450 to a first closure velocityv1. As the anvil 25007 closes, the FTC increases 21442 until time t1. Attime t1, the control circuit 21002 determines that tissue distributionis skewed toward zone 1, as depicted in FIGS. 93, 96. In response, asindicated by the process 25030, the processor 462 may adjust the speedof the motor 482 to allow the tissue “T3” sufficient time to creepoutward toward the zone 2 and/or zone 3.

FIG. 103 illustrates a diagram 6000 of a surgical instrument 6002centered on a staple line 6003 using the benefit of centering tools andtechniques described in connection with FIGS. 104-114, in accordancewith at least one aspect of the present disclosure. As used in thefollowing description of FIGS. 104-114 a staple line may includemultiple rows of staggered staples and typically includes two or threerows of staggered staples, without limitation. The staple line may be adouble staple line 6004 formed using a double-stapling technique asdescribed in connection with FIGS. 104-108 or may be a linear stapleline 6052 formed using a linear transection technique as described inconnection with FIGS. 109-114. The centering tools and techniquesdescribed herein can be used to align the instrument 6002 located in onepart of the anatomy with either the staple line 6003 or with anotherinstrument located in another part of the anatomy without the benefit ofa line of sight. The centering tools and techniques include displayingthe current alignment of the instrument 6002 adjacent to previousoperations. The centering tool is useful, for example, duringlaparoscopic-assisted rectal surgery that employ a double-staplingtechnique, also referred to as an overlapping stapling technique. In theillustrated example, during a laparoscopic-assisted rectal surgicalprocedure, a circular stapler 6002 is positioned in the rectum 6006 of apatient within the pelvic cavity 6008 and a laparoscope is positioned inthe peritoneal cavity.

During the laparoscopic-assisted rectal surgery, the colon is transectedand sealed by the staple line 6003 having a length “l.” Thedouble-stapling technique uses the circular stapler 6002 to create anend-to-end anastomosis and is currently used widely inlaparoscopic-assisted rectal surgery. For a successful formation of ananastomosis using a circular stapler 6002, the anvil trocar 6010 of thecircular stapler 6002 should be aligned with the center “l/2” of thestaple line 6003 transection before puncturing through the center “l/2”of the staple line 6003 and/or fully clamping on the tissue beforefiring the circular stapler 6002 to cut out the staple overlap portion6012 and forming the anastomosis. Misalignment of the anvil trocar 6010to the center of the staple line 6003 transection may result in a highrate of anastomotic failures. This technique may be applied toultrasonic instruments, electrosurgical instruments, combinationultrasonic/electrosurgical instruments, and/or combination surgicalstapler/electrosurgical instruments. Several techniques are nowdescribed for aligning the anvil trocar 6010 of the circular stapler6002 to the center “l/2” of the staple line 6003.

In one aspect, as described in FIGS. 104-106 and with reference also toFIGS. 1-11, to show interaction with an interactive surgical system 100environment including a surgical hub 106, 206, the present disclosureprovides an apparatus and method for detecting the overlapping portionof the double staple line 6004 in a laparoscopic-assisted rectal surgerycolorectal transection using a double stapling technique. Theoverlapping portion of the double staple line 6004 is detected and thecurrent location of the anvil trocar 6010 of the circular stapler 6002is displayed on a surgical hub display 215 coupled to the surgical hub206. The surgical hub display 215 displays the alignment of a circularstapler 6002 cartridge relative to the overlapping portion of the doublestaple line 6004, which is located at the center of the double stapleline 6004. The surgical hub display 215 displays a circular imagecentered around the overlapping double staple line 6004 region to ensurethat the overlapping portion of the double staple line 6004 is containedwithin the knife of the circular stapler 6002 and therefore removedfollowing the circular firing. Using the display, the surgeon aligns theanvil trocar 6010 with the center of the double staple line 6004 beforepuncturing through the center of the double staple line 6004 and/orfully clamping on the tissue before firing the circular stapler 6002 tocut out the staple overlap portion 6012 and form the anastomosis.

FIGS. 104-108 illustrate a process of aligning an anvil trocar 6010 of acircular stapler 6022 to a staple overlap portion 6012 of a doublestaple line 6004 created by a double-stapling technique, in accordancewith at least one aspect of the present disclosure. The staple overlapportion 6012 is centered on the double staple line 6004 formed by adouble-stapling technique. The circular stapler 6002 is inserted intothe colon 6020 below the double staple line 6004 and a laparoscope 6014is inserted through the abdomen above the double staple line 6004. Alaparoscope 6014 and a non-contact sensor 6022 are used to determine ananvil trocar 6010 location relative to the staple overlap portion 6012of the double staple line 6004. The laparoscope 6014 includes an imagesensor to generate an image of the double staple line 6004. The imagesensor image is transmitted to the surgical hub 206 via the imagingmodule 238. The sensor 6022 generates a signal 6024 that detects themetal staples using inductive or capacitive metal sensing technology.The signal 6024 varies based on the position of the anvil trocar 6010relative to the staple overlap portion 6004. A centering tool 6030presents an image 6038 of the double staple line 6004 and a targetalignment ring 6032 circumscribing the image 6038 of the double stapleline 6004 centered about an image 6040 of the staple overlap portion6012 on the surgical hub display 215. The centering tool 6030 alsopresents a projected cut path 6034 of an anvil knife of a circularstapler 6002. The alignment process includes displaying an image 6038 ofthe double staple line 6004 and a target alignment ring 6032circumscribing the image 6038 of the double staple line 6004 centered onthe image 6040 of the staple overlap portion 6012 to be cut out by thecircular knife of the circular stapler 6002. Also displayed is an imageof a crosshair 6036 (X) relative to the image 6040 of the staple overlapportion 6012.

FIG. 104 illustrates an anvil trocar 6010 of a circular stapler 6002that is not aligned with a staple overlap portion 6012 of a doublestaple line 6004 created by a double-stapling technique. The doublestaple line 6004 has a length “l” and the staple overlap portion 6012 islocated midway along the double staple line 6004 at “l/2.” As shown inFIG. 104, the circular stapler 6002 is inserted into a section of thecolon 6020 and is positioned just below the double staple line 6004transection. A laparoscope 6014 is positioned above the double stapleline 6004 transection and feeds an image of the double staple line 6004and staple overlap portion 6012 within the field of view 6016 of thelaparoscope 6014 to the surgical hub display 215. The position of theanvil trocar 6010 relative to the staple overlap portion 6012 isdetected by a sensor 6022 located on the circular stapler 6002. Thesensor 6022 also provides the position of the anvil trocar 6010 relativeto the staple overlap portion 6012 to the surgical hub display 215.

As shown in FIG. 104, the projected path 6018 of the anvil trocar 6010is shown along a broken line to a position marked by an X. As shown inFIG. 104, the projected path 6018 of the anvil trocar 6010 is notaligned with the staple overlap portion 6012. Puncturing the anviltrocar 6010 through the double staple line 6044 at a point off thestaple overlap portion 6012 could lead to an anastomotic failure. Usingthe anvil trocar 6010 centering tool 6030 described in FIG. 106, thesurgeon can align the anvil trocar 6010 with the staple overlap portion6012 using the images displayed by the centering tool 6030. For example,in one implementation the sensor 6022 is an inductive sensor. Since thestaple overlap portion 6012 contains more metal than the rest of thelateral portions of the double staple line 6004, the signal 6024 ismaximum when the sensor 6022 is aligned with and proximate to the stapleoverlap portion 6012. The sensor 6022 provides a signal to the surgicalhub 206 that indicates the location of the anvil trocar 6010 relative tothe staple overlap portion 6012. The output signal is converted to avisualization of the location of the anvil trocar 6010 relative to thestaple overlap portion 6012 that is displayed on the surgical hubdisplay 215.

As shown in FIG. 105, the anvil trocar 6010 is aligned with the stapleoverlap portion 6012 at the center of the double staple line 6004created by a double-stapling technique. The surgeon can now puncture theanvil trocar 6010 through the staple overlap portion 6012 of the doublestaple line 6004 and/or fully clamp on the tissue before firing thecircular stapler 6002 to cut out the staple overlap portion 6012 andform an anastomosis.

FIG. 106 illustrates a centering tool 6030 displayed on a surgical hubdisplay 215, the centering tool providing a display of a staple overlapportion 6012 of a double staple line 6004 created by a double-stalingtechnique, where the anvil trocar 6010 is not aligned with the stapleoverlap portion 6012 of the double staple line 6004 as shown in FIG.104. The centering tool 6030 presents an image 6038 on the surgical hubdisplay 215 of the double staple line 6004 and an image 6040 of thestaple overlap portion 6012 received from the laparoscope 6014. A targetalignment ring 6032 centered about the image 6040 of the staple overlapportion 6012 circumscribes the image 6038 of the double staple line 6004to ensure that the staple overlap portion 6012 is located within thecircumference of the projected cut path 6034 of the circular stapler6002 knife when the projected cut path 6034 is aligned to the targetalignment ring 6032. The crosshair 6036 (X) represents the location ofthe anvil trocar 6010 relative to the staple overlap portion 6012. Thecrosshair 6036 (X) indicates the point through the double staple line6004 where the anvil trocar 6010 would puncture if it were advanced fromits current location.

As shown in FIG. 106, the anvil trocar 6010 is not aligned with thedesired puncture through location designated by the image 6040 of thestaple overlap portion 6012. To align the anvil trocar 6010 with thestaple overlap portion 6012 the surgeon manipulates the circular stapler6002 until the projected cut path 6034 overlaps the target alignmentring 6032 and the crosshair 6036 (X) is centered on the image 6040 ofthe staple overlap portion 6012. Once alignment is complete, the surgeonpunctures the anvil trocar 6010 through the staple overlap portion 6012of the double staple line 6004 and/or fully clamps on the tissue beforefiring the circular stapler 6002 to cut out the staple overlap portion6012 and form the anastomosis.

As discussed above, the sensor 6022 is configured to detect the positionof the anvil trocar 6010 relative to the staple overlap portion 6012.Accordingly, the location of the crosshair 6036 (X) presented on thesurgical hub display 215 is determined by the surgical stapler sensor6022. In another aspect, the sensor 6022 may be located on thelaparoscope 6014, where the sensor 6022 is configured to detect the tipof the anvil trocar 6010. In other aspects, the sensor 6022 may belocated either on the circular stapler 6022 or the laparoscope 6014, orboth, to determine the location of the anvil trocar 6010 relative to thestaple overlap portion 6012 and provide the information to the surgicalhub display 215 via the surgical hub 206.

FIGS. 107 and 108 illustrate a before image 6042 and an after image 6043of a centering tool 6030, in accordance with at least one aspect of thepresent disclosure. FIG. 107 illustrates an image of a projected cutpath 6034 of an anvil trocar 6010 and circular knife before alignmentwith the target alignment ring 6032 circumscribing the image 6038 of thedouble staple line 6004 over the image 6040 of the staple overlapportion 6040 presented on a surgical hub display 215. FIG. 108illustrates an image of a projected cut path 6034 of an anvil trocar6010 and circular knife after alignment with the target alignment ring6032 circumscribing the image 6038 of the double staple line 6004 overthe image 6040 of the staple overlap portion 6040 presented on asurgical hub display 215. The current location of the anvil trocar 6010is marked by the crosshair 6036 (X), which as shown in FIG. 107, ispositioned below and to the left of center of the image 6040 of thestaple overlap portion 6040. As shown in FIG. 108, as the surgeon movesthe anvil trocar 6010 of the along the projected path 6046, theprojected cut path 6034 aligns with the target alignment ring 6032. Thetarget alignment ring 6032 may be displayed as a greyed out alignmentcircle overlaid over the current position of the anvil trocar 6010relative to the center of the double staple line 6004, for example. Theimage may include indication marks as to which direction to move. Thetarget alignment ring 6032 may be shown in bold, change color orhighlight when it is located within a predetermined distance of centerwithin acceptable limits.

In another aspect, the sensor 6022 may be configured to detect thebeginning and end of a linear staple line in a colorectal transectionand to provide the position of the current location of the anvil trocar6010 of the circular stapler 6002. In another aspect, the presentdisclosure provides a surgical hub display 215 to present the circularstapler 6002 centered on the linear staple line, which would create evendog ears, and to provide the current position of the anvil trocar 6010to allow the surgeon to center or align the anvil trocar 6010 as desiredbefore puncturing and/or fully clamping on tissue prior to firing thecircular stapler 6002.

In another aspect, as described in FIGS. 109-111 and with reference alsoto FIGS. 1-11, in a laparoscopic-assisted rectal surgery colorectaltransection using a linear stapling technique, the beginning and end ofthe linear staple line 6052 is detected and the current location of theanvil trocar 6010 of the circular stapler 6002 is displayed on asurgical hub display 215 coupled to the surgical hub 206. The surgicalhub display 215 displays a circular image centered on the double stapleline 6004, which would create even dog ears and the current position ofthe anvil trocar 6002 is displayed to allow the surgeon to center oralign the anvil trocar 6010 before puncturing through the linear stapleline 6052 and/or fully clamping on the tissue before firing the circularstapler 6002 to cut out the center 6050 of the linear staple line 6052to form an anastomosis.

FIGS. 109-112 illustrate a process of aligning an anvil trocar 6010 of acircular stapler 6022 to a center 6050 of a linear staple line 6052created by a linear stapling technique, in accordance with at least oneaspect of the present disclosure. FIGS. 109 and 110 illustrate alaparoscope 6014 and a sensor 6022 located on the circular stapler 6022to determine the location of the anvil trocar 6010 relative to thecenter 6050 of the linear staple line 6052. The anvil trocar 6010 andthe sensor 6022 is inserted into the colon 6020 below the linear stapleline 6052 and the laparoscope 6014 is inserted through the abdomen abovethe linear staple line 6052.

FIG. 109 illustrates the anvil trocar 6010 out of alignment with thecenter 6050 of the linear staple line 6052 and FIG. 110 illustrates theanvil trocar 6010 in alignment with the center 6050 of the linear stapleline 6052. The sensor 6022 is used to detect the center 6050 of thelinear staple line 6052 to align the anvil trocar 6010 with the centerof the staple line 6052. In one aspect, the center 6050 of the linearstaple line 6052 may be located by moving the circular stapler 6002until one end of the linear staple line 6052 is detected. An end may bedetected when there are no more staples in the path of the sensor 6022.Once one of the ends is reached, the circular stapler 6002 is movedalong the linear staple line 6053 until the opposite end is detected andthe length “I” of the linear staple line 6052 is determined bymeasurement or by counting individual staples by the sensor 6022. Oncethe length of the linear staple line 6052 is determined, the center 6050of the linear staple line 6052 can be determined by dividing the lengthby two “l/2.”

FIG. 111 illustrates a centering tool 6054 displayed on a surgical hubdisplay 215, the centering tool providing a display of a linear stapleline 6052, where the anvil trocar 6010 is not aligned with the stapleoverlap portion 6012 of the double staple line 6004 as shown in FIG.109. The surgical hub display 215 presents a standard reticle field ofview 6056 of the laparoscopic field of view 6016 of the linear stapleline 6052 and a portion of the colon 6020. The surgical hub display 215also presents a target ring 6062 circumscribing the image center of thelinear staple line and a projected cut path 6064 of the anvil trocar andcircular knife. The crosshair 6066 represents the location of the anviltrocar 6010 relative to the center 6050 of the linear staple line 6052.The crosshair 6036 (X) indicates the point through the linear stapleline 6052 where the anvil trocar 6010 would puncture if it were advancedfrom its current location.

As shown in FIG. 111, the anvil trocar 6010 is not aligned with thedesired puncture through location designated by the offset between thetarget ring 6062 and the projected cut path 6064. To align the anviltrocar 6010 with the center 6050 of the linear staple line 6052 thesurgeon manipulates the circular stapler 6002 until the projected cutpath 6064 overlaps the target alignment ring 6062 and the crosshair 6066is centered on the image 6040 of the staple overlap portion 6012. Oncealignment is complete, the surgeon punctures the anvil trocar 6010through the center 6050 of the linear staple line 6052 and/or fullyclamps on the tissue before firing the circular stapler 6002 to cut outthe staple overlap portion 6012 and form the anastomosis.

In one aspect, the present disclosure provides an apparatus and methodfor displaying an image of an linear staple line 6052 using a lineartransection technique and an alignment ring or bullseye positioned as ifthe anvil trocar 6010 of the circular stapler 6022 were centeredappropriately along the linear staple line 6052. The apparatus displaysa greyed out alignment ring overlaid over the current position of theanvil trocar 6010 relative to the center 6050 of the linear staple line6052. The image may include indication marks to assist the alignmentprocess by indication which direction to move. the anvil trocar 6010.The target alignment ring 6032 may be shown in bold, change color or maybe highlighted when it is located within a predetermined distance ofcenter within acceptable limits.

With reference now to FIGS. 109-112, FIG. 112 is an image 6080 of astandard reticle field view 6080 of a linear staple line 6052transection of a surgical as viewed through a laparoscope 6014 displayedon the surgical hub display 215, in accordance with at least one aspectof the present disclosure. In a standard reticle view 6080, it isdifficult to see the linear staple line 6052 in the standard reticlefield of view 6056. Further, there are no alignment aids to assist withalignment and introduction of the anvil trocar 6010 to the center 6050of the linear staple line. This view does not show an alignment circleor alignment mark to indicate if the circular stapler is centeredappropriately and does not show the projected trocar path. In this viewit also difficult to see the staples because there is no contrast withthe background image.

With reference now to FIGS. 109-113, FIG. 113 is an image 6082 of alaser-assisted reticle field of view 6072 of the surgical site shown inFIG. 112 before the anvil trocar 6010 and circular knife of the circularstapler 6002 are aligned to the center 6050 of the linear staple line6052, in accordance with at least one aspect of the present disclosure.The laser-assisted reticle field of view 6072 provides an alignment markor crosshair 6066 (X), currently positioned below and to the left ofcenter of the linear staple line 6052 showing the projected path of theanvil trocar 6010 to assist positioning of the anvil trocar 6010. Inaddition to the projected path marked by the crosshair 6066 of the anviltrocar 6010, the image 6082 displays the staples of the linear stapleline 6052 in a contrast color to make them more visible against thebackground. The linear staple line 6052 is highlighted and a bullseyetarget 6070 is displayed over the center 6050 of the linear staple line6052. Outside of the laser-assisted reticle field of view 6072, theimage 6082 displays a status warning box 6068, a suggestion box 6074, atarget ring 6062, and the current alignment position of the anvil trocar6010 marked by the crosshair 6066 relative to the center 6050 of thelinear staple line 6052. As shown in FIG. 113, the status warning box6068 indicates that the trocar is “MISALIGNED” and the suggestion box6074 states “Adjust trocar to center staple line.”

With reference now to FIGS. 109-114, FIG. 114 is an image 6084 of alaser-assisted reticle field of view 6072 of the surgical site shown inFIG. 113 after the anvil trocar 6010 and circular knife of the circularstapler 6002 are aligned to the center 6050 of the linear staple line6052, in accordance with at least one aspect of the present disclosure.The laser-assisted reticle field of view 6072 provides an alignment markor crosshair 6066 (X), currently positioned below and to the left ofcenter of the linear staple line 6052 showing the projected path of theanvil trocar 6010 to assist positioning of the anvil trocar 6010. Inaddition to the projected path marked by the crosshair 6066 of the anviltrocar 6010, the image 6082 displays the staples of the linear stapleline 6052 in a contrast color to make them more visible against thebackground. The linear staple line 6052 is highlighted and a bullseyetarget 6070 is displayed over the center 6050 of the linear staple line6052. Outside of the laser-assisted reticle field of view 6072, theimage 6082 displays a status warning box 6068, a suggestion box 6074, atarget ring 6062, and the current alignment position of the anvil trocar6010 marked by the crosshair 6066 relative to the center 6050 of thelinear staple line 6052. As shown in FIG. 113, the status warning box6068 indicates that the trocar is “MISALIGNED” and the suggestion box6074 states “Adjust trocar to center staple line.”

FIG. 114 is a laser assisted view of the surgical site shown in FIG. 113after the anvil trocar 6010 and circular knife are aligned to the centerof the staple line 6052. In this view, inside the field of view 6072 ofthe laser-assisted reticle, the alignment mark crosshair 6066 (X) ispositioned over the center of the staple line 6052 and the highlightedbullseye target to indicate alignment of the trocar to the center of thestaple line. Outside the field of view 6072 of the laser-assistedreticle, the status warning box indicates that the trocar is “ALIGNED”and the suggestion is “Proceed trocar introduction.”

Referring now to FIGS. 115-119, not only the amount and location of thetissue can affect the stapling outcome but also the nature, type, orstate of the tissue. For example, irregular tissue distribution alsomanifests in situations that involve stapling previously stapled tissuesuch as, for example, in J-Pouch procedures, also known as Ileal PouchAnal Anastomosis, and End-To End anastomosis procedures. Poorpositioning and distribution of the previously stapled tissue within theend effector of a staple cartridge may cause the previously fired staplelines to be concentrated in one zone over another within the endeffector, which negatively affects the outcome of such procedures.

Aspects of the present disclosure present a surgical stapling instrumentthat includes an end effector configured to staple tissue clampedbetween a first jaw and a second jaw of the end effector. In one aspect,positioning and orientation of previously stapled tissue within the endeffector is determined by measuring and comparing tissue impedance at anumber of predetermined zones within the end effector. In variousaspects, tissue impedance measurements can also be utilized to identifyoverlapped layers of tissue and their position within an end effector.

FIGS. 115, 117, 118 illustrate an end effector 25500 of a circularstapler that includes a staple cartridge 25502 and an anvil 25504configured to grasp tissue therebetween. The anvil 25504 and staplecavities 25505 of the staple cartridge 25502 are removed from FIG. 115to highlight other features of the end effector 25500. The staplecartridge 25502 includes four predetermined zones (Zone 1, Zone 2, Zone3, Zone4) defined by sensing circuits (S₁, S₂, S₃, S₄), in accordancewith the present disclosure.

FIG. 116 illustrates another end effector 25510 of a circular staplerthat includes staple cartridge 25512 and an anvil configured to grasptissue therebetween. The anvil and staple cavities of the staplecartridge 25512 are removed to highlight other features of the endeffector 25510. The staple cartridge 25512 includes eight predeterminedzones (Zone 1-Zone 8) defined by sensing circuits (S₁-S₈), in accordancewith the present disclosure. The zones defined in each of the circularstaplers of FIGS. 115 and 116 are equal, or at least substantiallyequal, in size, and are arranged circumferentially around a longitudinalaxis extending longitudinally through shafts of the circular staplers.

As described above, a previously stapled tissue is a tissue thatincludes staples that were previously deployed into the tissue. Circularstaplers are often utilized in stapling previously stapled tissue tounstapled tissue (e.g. J-pouch procedures), as illustrated in FIG. 118,and stapling previously stapled tissue to other previously stapledtissue (e.g. End-To-End Anastomosis procedures), as illustrated in FIG.117.

The presence of the staples in tissue affects the tissue impedance asthe staples usually have different conductivity than tissue. The presentdisclosure presents various tools and techniques for monitoring andcomparing tissue impedances at the predetermined zones of an endeffector (e.g. end effectors 25500, 25510) of a circular stapler todetermine an optimal positioning and orientation of a previously-stapledtissue with respect to the end effector.

The examples on the left sides of FIGS. 117, 118 demonstrate properlypositioned and oriented previously-stapled tissue with respect topredetermined zones of a circular stapler. The previously-stapled tissueproperly extends through the center of the staple cartridge 25502, andonly once intersects a predetermined zone. The bottom left side of FIGS.117, 118 demonstrate staples 25508 of the staple cartridge 25502deployed into properly positioned and oriented previously-stapledtissue.

The examples on the right sides of FIGS. 117, 118 demonstrate poorlypositioned and oriented previously-stapled tissue. Thepreviously-stapled tissue is off center (FIG. 118) or overlaps (FIG. 31)at one or more predetermined zones. The bottom right side of FIGS. 117,118 demonstrate staples 25508 of the staple cartridge 25502 deployedinto poorly positioned and oriented previously-stapled tissue.

As used in connection with FIGS. 115-119 a staple line may includemultiple rows of staggered staples and typically includes two or threerows of staggered staples, without limitation. In the examples of FIG.117, a circular stapler of FIG. 115 is utilized to staple two tissuesthat include previously deployed staple lines SL1, SL2. In the exampleto the left of FIG. 117, which represents properly positioned andorientated staple lines SL1, SL2, each of Zone 1 through Zone 4 receivesa discrete portion of one of the staple lines SL1, SL2. The first stapleline SL1 extends across Zone 2 and Zone 4, while the second staple lineSL2, which intersects the first staple line SL1 at a central point,extends across Zone 1 and Zone 3. Accordingly, the measured impedancesin the four zones will be equal, or at least substantially equal, to oneanother, and will be less than the impedance of an unstapled tissue.

On the contrary, in the example to the right of FIG. 117, whichrepresents improperly positioned and orientated staple lines SL1, SL2,the staple lines SL1, SL2 overlap, or extend substantially on top of oneanother, across Zone 1 and Zone 3 yielding lower impedance measurementsin zone 1 and Zone 3 as compared to Zone 2 and Zone 4.

FIGS. 119 and 120 illustrate staple lines SL1, SL2 in an End-To-Endanastomosis procedure performed by an end effector 25510 of a circularstapler of FIG. 116 that includes eight predetermined zones (zone 1-Zone8) defined by eight sensing circuits S₁-S₈, as described above. Theanvil of the end effector 25510 and staple cavities of the staplecartridge 25512 are removed from FIGS. 119 and 120 to highlight otherfeatures of the end effector 25510.

FIGS. 121 and 122 illustrate measured tissue impedances based on sensorsignals from the sensing circuits S₁-S₈. The individual measurementsdefine tissue impedance signatures. Vertical axes 25520, 25520′represent an angle of orientation (θ), while vertical axes 25522, 25522′list corresponding predetermined zones (Zone 1-Zone 8). Tissue impedance(Z) is depicted on horizontal axes 25524, 25524′.

In the example of FIGS. 119 and 121, the impedance measurementsrepresent properly positioned and orientated staple lines SL1, SL2. Asillustrated in FIG. 119, the staple lines SL1, SL2 extend through Zone1, Zone 3, Zone 5, and Zone 7, and only overlap at a central point ofthe staple cartridge 25512. Since the previously-stapled tissue isevenly distributed among Zone 1, Zone 3, Zone 5, and Zone 7, tissueimpedance measurements at such zones are the same, or at leastsubstantially the same, in magnitude, and are significantly less thantissue impedance measurements at Zone 2, Zone 4, Zone 6, and Zone 8,which did not receive previously-stapled tissue.

Conversely, in the example of FIGS. 120, 122, the impedance measurementsrepresent improperly positioned and orientated staple lines SL1, SL2. Asillustrated in FIG. 120, the staple lines SL1, SL2 overlap on top of oneanother extending only through Zone 1 and Zone 5. Accordingly, tissueimpedance measurements at Zone 1 and Zone 5 are significantly lower inmagnitude than the remaining zones, which did not receivepreviously-stapled tissue.

FIGS. 123 and 124 illustrate a staple line SL3 in a J-Pouch procedureperformed by an end effector 25510 of a circular stapler of FIG. 116that includes eight predetermined zones (Zone 1-Zone 8) defined by eightsensing circuits S₁-S₈, as described above. The anvil of the endeffector 25510 and staple cavities of the staple cartridge 25512 areremoved from FIGS. 123 and 124 to highlight other features of the endeffector 25510.

FIGS. 125 and 126 illustrate measured tissue impedances based on sensorsignals from the sensing circuits S₁-S₈. The individual measurementsdefine tissue impedance signatures. Vertical axes 25526, 25526′represent an angle of orientation (θ), while vertical axes 25528, 25528′list corresponding predetermined zones (Zone 1-Zone 8). Tissue impedance(Z) is depicted on horizontal axes 25530, 25530′.

In the example of FIGS. 123 and 125, the impedance measurementsrepresent a properly positioned and orientated staple line SL3. Asillustrated in FIG. 123, the staple line SL3 extends only through Zone 1and Zone 5. Since the previously-stapled tissue is evenly distributedamong Zone 1 and Zone 5, tissue impedance measurements at such zones arethe same, or at least substantially the same, in magnitude, and aresignificantly less than tissue impedance measurements at the remainingzones, which did not receive previously-stapled tissue.

Conversely, in the example of FIGS. 124, 126, the impedance measurementsrepresent an improperly positioned and orientated staple line SL3. Asillustrated in FIG. 124, the staple line SL3 extends through Zone 4,Zone 5, and Zone 6, which are all on one side of the staple cartridge25510. Accordingly, tissue impedance measurements at Zone 4, Zone 5, andZone 6 are significantly lower in magnitude than the remaining zones,which did not receive previously-stapled tissue.

In various aspects, a circular stapler (e.g. the circular stapler ofFIG. 115 and the circular stapler of FIG. 116) further includes acontrol system 25470 (FIG. 102), which can be configured to furtheranalyze impedance measurements determined from the received sensorsignals of the sensing circuits of the circular stapler. In certainaspects, the control system 25470, as illustrated in FIG. 102, includesa microcontroller 461 that can be configured to determine a geometricparameter of one or more previously deployed staple lines, as shown inconnection with FIGS. 115-126. In certain instances, the microcontroller461 can also be configured to determine an alignment aspect of thecircular stapler, as shown in connection with FIGS. 103-114. In certaininstances, the microcontroller 461 can also be configured to determinethe location of a circular trocar of the circular staple, the length andcenterline of a pre-existing staple line, and/or the center intersectionof two sequential lines, as shown in connection with FIGS. 103-114.

The microcontroller 461 may alert the surgical operator through thedisplay 473, for example, of a detected improper positioning and/ororientation of previously stapled tissue. Other audio, haptic, and/orvisual means can also be employed. The microcontroller 461 may also takesteps to prevent the tissue stapling. For example, the microcontroller461 may signal the motor driver 492 to deactivate the motor 482. Incertain instances, the microcontroller 461 may recommend a new positionand/or orientation to the surgical operator.

In various aspects, the circular staplers of the present disclosure arecommunicatively coupled to a surgical hub 106 (FIG. 3, FIG. 4), 206(FIG. 206) through a wired and/or wireless communication channel. Datagathered by such circular stapler can be transmitted to the surgical hub106, 206, which may further transmit the data to a cloud based system104, 204, for additional analysis.

FIG. 127 illustrates a logic flow diagram of a process 25600 depicting acontrol program or a logic configuration for properly positioning apreviously-stapled tissue within an end effector (e.g. end effectors25500, 25510) of a surgical stapler. In one aspect, the process 25600 isexecuted by a control circuit 500 (FIG. 13). In another aspect, theprocess 25600 is executed by a combinational logic circuit 510 (FIG.14). In yet another aspect, the process 25600 is executed by asequential logic circuit 520 (FIG. 15).

For illustrative purposes, the following description depicts the process25600 as being executable by a control circuit that includes acontroller 461, which includes a processor 461. A memory 468 storesprogram instructions, which are executable by the processor 461 toperform the process 25600.

The process 25600 determines 25602 the type of surgical procedure beingperformed by the surgical stapler. The surgical procedure type can bedetermined using various techniques described under the heading“Situational Awareness”. The processor 25600 then selects 25604, basedon the determined surgical procedure type, a tissue impedance signaturefor a properly positioned previously-stapled tissue. As described above,a properly positioned previously-stapled tissue in a J-pouch procedure,for example, comprises a different tissue impedance signature than in anEnd-To-End Anastomosis procedure, for example.

The process 25600 then determines 25606 whether measured tissueimpedances in the predetermined zones correspond to the selected tissueimpedance signature. If not, the processor 461 may alert 25608 the userand/or override 25610 the tissue treatment. In one aspect, the processor461 may alert 25608 the user through the display 473. In addition, theprocessor 461 may override 25610 the tissue treatment by preventing theend effector from completing its firing, which can be accomplished bycausing the motor driver 492 to stop the motor 482 (FIG. 102), forexample.

If, however, the measured tissue impedances in the predetermined zonescorrespond to the selected tissue impedance signature, the processor 461permits the end effector to proceed 25612 with the tissue treatment.

Referring generally to FIGS. 128-134, tissue overhang is a phenomenonthat occurs when tissue such as, for example, a blood vessel (BV), whichis grasped between the jaws of a surgical end effector, extends beyondan optimal treatment region of the end effector. As such, theoverhanging tissue may not receive the treatment applied by the endeffector. In cases where the tissue includes a blood vessel, and thetreatment involves sealing and cutting the blood vessel (BV), theunsealed overhanging portion of the blood vessel may leak leading toundesirable consequences.

Aspects of the present disclosure present a surgical instrumentincluding a circuit configured to detect overhanging tissue in an endeffector of the surgical instrument. Aspects of the present disclosurealso present a surgical instrument including a circuit configured todetect tissue extending beyond a predetermined treatment region in anend effector of the surgical instrument.

In various examples, an end effector 25700 of a surgical instrument25701 includes a first jaw 25702 and a second jaw 25704. The 25701 issimilar in many respects to other surgical instruments discloseselsewhere herein such as, for example, the surgical instrument 150010.At least one of the first jaw 25702 and the second jaw 25704 is movableto transition the end effector 25700 between an open configuration(FIGS. 128, 129, 132) to a closed configuration (FIGS. 130, 131, 133,134). In the example of FIGS. 128-134, the end effector 25700 includes astaple cartridge 25708 including staples deployable into tissue graspedbetween the jaws 25702 and 25704, and deformable by an anvil 25710. Inother examples, an end effector in accordance with the presentdisclosure, may treat tissue by application of ultrasonic and/orradiofrequency energy.

The end effector 25700 further includes a flex circuit 25706 comprisinga continuity sensor for detecting overhanging tissue. The overhangingtissue, when in contact with the continuity sensor, as illustrated inFIGS. 131, 134, establishes an electrical path that causes a flow ofcurrent through the flex circuit 25706. The current flow indicates thepresence of overhanging tissue.

The jaws 25702, 25704 define a treatment region 25714 therebetween wheretissue treatment is applied in the closed configuration, as illustratedin FIGS. 131, 134.

Bent tips or noses 25716, 25718 are defined in the jaws 25702, 25704distal to the treatment region 25714. A stepped feature 25720 maintainsa minimum distance or gap between the jaws 25702 and 25704 at the bentnoses 25716, 25718 in the closed configuration.

The flex circuit 25706 is nestled in the nose 25716 of the first jaw25702 such that, in the absence of tissue, a gap 25724 is maintainedabove the flex circuit 25706 by the stepped feature 25720.

In the example of FIG. 128-134, the end effector 25700 includes atreatment region 25714 residing between the anvil 25710 and the staplecartridge 25708. To staple tissue grasped by the end effector 25700 inthe treatment region 25714, staples are deployed from the staplecartridge 25708 into the tissue, and are deformed by the anvil 25710. Inother example, a treatment region of an end effector 25700 may sealtissue by application of radiofrequency and/or ultrasonic energy totissue at a treatment region.

In the example of FIGS. 128-134, a continuity sensor is disposed onto adistal portion of the staple cartridge 25708, and is defined by aninsulated flex circuit 25706 wired through contacts coupled tocorresponding contacts in a channel 25726 of the first jaw 25702 that isconfigured to receive the staple cartridge. A sensor signal indicativeof the presence of overhanding tissue passes through the contacts to acontrol system such as, for example, the control system 470 (FIG. 12).

The flex circuit 25706 extends distally from a flat, or substantiallyflat, portion 25728 of the staple cartridge 25708 between the steppedfeature 25720 and the bent nose 25716. The flex circuit 25706 furtherextends down a ramp 25730 defined by the bent nose 25716, and extendingfrom a distal edge of the flat portion 25728. Tissue extending beyondthe stepped feature 25720 onto the flat portion 25728 and/or the ramp25730, triggers the continuity sensor causing a sensor signal to betransmitted to the control system 470 (FIG. 12).

Distal ends of the bent noses include corresponding alignment features25722, 25732 positioned distal to the continuity sensor. In the exampleof FIGS. 128-134, the alignment feature 25722 comprises a raised surfaceand the alignment feature 25732 comprises a corresponding recessedsurface configured to receive the raised surface of the alignmentfeature 25722.

Although the continuity sensor is disposed onto the staple cartridge25708, this should not be construed as limiting. For example, in certaininstances, the continuity sensor can be disposed onto the distal nose25718 of the anvil 25710.

In various aspects, a surgical instrument including an end effector25700, as shown in FIGS. 128-134 can be a handheld surgical instrument.Alternatively, end effector 25700 can be incorporated into a roboticsystem as a component of a robotic arm. Additional details on roboticsystems are disclosed in U.S. Provisional Patent Application No.62/611,339, filed Dec. 28, 2017, which is incorporated herein byreference in its entirety.

In certain instances, a surgical instrument 25701 including an endeffector 25700, as shown in FIGS. 128-134, can be communicativelycoupled to a surgical hub (e.g. surgical hubs 106 (FIG. 3, FIG. 4), 206(FIG. 206)) through a wired and/or wireless communication channel, asdescribed in greater detail in connection with FIGS. 1-11.

In various aspects, when tissue overhanging is detected, a display 473may show at least a partial view of the end effector 25700 such as, forexample, a cartridge deck of the staple cartridge 25708 with tissueoverhanging therefrom. Furthermore, impedance or another tissuecompression estimation sensing means or 3D stacking or anothervisualization means can be employed to further indicate the amount ofoverhanging tissue sensed between the bent noses 25716, 25718.

EXAMPLES

Various aspects of the subject matter described herein are set out inthe following examples:

Example 1

A surgical stapling instrument comprises an end effector. The endeffector comprises a first jaw and a second jaw movable relative to thefirst jaw between an open configuration and a closed configuration tograsp tissue between the first jaw and the second jaw. The end effectorfurther comprises an anvil and a staple cartridge. The staple cartridgecomprises staples deployable into the tissue and deformable by theanvil. The surgical stapling system further comprises a control circuit.The control circuit is configured to determine tissue impedances atpredetermined zones, detect an irregularity in tissue distributionwithin the end effector based on the tissue impedances, and adjust aclosure parameter of the end effector in accordance with theirregularity.

Example 2

The surgical stapling instrument of Example 1, wherein the end effectorcomprises sensing circuits at the predetermined zones.

Example 3

The surgical stapling instrument of Example 1 or 2, wherein thepredetermined zones are separated by insulating elements.

Example 4

The surgical stapling instrument of Example 1, 2, or 3, wherein thepredetermined zones comprise an inner predetermined zone, an outerpredetermined zone, and an intermediate predetermined zone between theinner predetermined zone and the outer predetermined zone.

Example 5

The surgical stapling instrument of Example 4, wherein detecting theirregularity in tissue distribution within the end effector comprisesdetermining that an average of the tissue impedances at the innerpredetermined zone and the outer predetermined zone is greater than thetissue impedance at the intermediate predetermined zone.

Example 6

The surgical stapling instrument of Example 1, 2, 3, 4, or 5, whereindetecting the irregularity in tissue distribution within the endeffector causes the control circuit to alert a user to release andreposition the tissue grasped by the end effector.

Example 7

The surgical stapling instrument of Example 4, wherein detecting theirregularity in tissue distribution within the end effector comprisesdetermining that an average of the tissue impedances at the innerpredetermined zone and the outer predetermined zone is less than orequal to the tissue impedance at the intermediate predetermined zone.Detecting the irregularity in tissue distribution within the endeffector further comprises determining that the tissue impedance of theinner predetermined zone is greater than the tissue impedance of theouter predetermined zone.

Example 8

The surgical stapling instrument of Example 1, 2, 3, 4, 5, 6, or 7,further comprising a motor configured to motivate the end effector totransition to the closed configuration, wherein detecting theirregularity in tissue distribution within the end effector causes thecontrol circuit to reduce a speed of the motor.

Example 9

The surgical stapling instrument of Example 1, 2, 3, 4, 5, 6, 7, or 8,wherein the closure parameter is closure velocity.

Example 10

The surgical stapling instrument of Example 1, 2, 3, 4, 5, 6, 7, 8, or9, wherein the control circuit is configured to pass at least onetherapeutic signal through tissue at each of the predetermined zones todetermine the tissue impedances.

Example 11

A surgical stapling instrument for stapling a previously-stapled tissuecomprises a shaft defining a longitudinal axis extending there through,and an end effector extending from the shaft. The end effector comprisesa first jaw and a second jaw movable relative to the first jaw betweenan open configuration and a closed configuration to grasp tissue betweenthe first jaw and the second jaw. The end effector further comprises ananvil and a staple cartridge. The staple cartridge comprises staplesdeployable into the previously-stapled tissue and deformable by theanvil. The end effector further comprises predetermined zones betweenthe anvil and the staple cartridge. The surgical stapling instrumentfurther comprises a circuit. The circuit is configured to measure tissueimpedances at the predetermined zones, compare the measured tissueimpedances to a predetermined tissue impedance signature of thepredetermined zones, and detect an irregularity in at least one ofposition and orientation of the previously-stapled tissue within the endeffector from the comparison.

Example 12

The surgical stapling instrument of Example 11, wherein the end effectorcomprises sensing circuits at the predetermined zones.

Example 13

The surgical stapling instrument of Example 11 or 12, wherein thepredetermined zones are separated by insulating elements.

Example 14

The surgical stapling instrument of Example 11, 12, or 13, wherein thepredetermined zones are circumferentially arranged about thelongitudinal axis.

Example 15

The surgical stapling instrument of Example 11, 12, 13, or 14, whereindetecting the irregularity causes the control circuit to alert a user.

Example 16

The surgical stapling instrument of Example 11, 12, 13, 14, or 15,wherein the control circuit is configured to pass at least onetherapeutic signal through tissue at each of the predetermined zones todetermine the tissue impedances.

Example 17

A surgical stapling instrument comprises an end effector. The endeffector comprises a first jaw and a second jaw movable relative to thefirst jaw between an open configuration and a closed configuration tograsp tissue between the first jaw and the second jaw. The end effectorfurther comprises an anvil and a staple cartridge. The staple cartridgecomprises staples deployable into the tissue and deformable by theanvil. The end effector further comprises predetermined zones betweenthe anvil and the staple cartridge. The surgical stapling instrumentfurther comprises a control circuit. The control circuit is configuredto determine an electrical parameter of the tissue at each of thepredetermined zones, detect an irregularity in tissue distributionwithin the end effector based on the determined electrical parameters,and adjust a closure parameter of the end effector in accordance withthe irregularity.

Example 18

The surgical stapling instrument of Example 17, wherein the end effectorcomprises sensing circuits at the predetermined zones.

Example 19

The surgical stapling instrument of Example 17 or 18, wherein thepredetermined zones are separated by insulating elements.

Example 20

The surgical stapling instrument of Example 17, 18, or 19, wherein theclosure parameter is closure velocity.

The foregoing detailed description has set forth various forms of thedevices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beunderstood by those within the art that each function and/or operationwithin such block diagrams, flowcharts, and/or examples can beimplemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof.Those skilled in the art will recognize that some aspects of the formsdisclosed herein, in whole or in part, can be equivalently implementedin integrated circuits, as one or more computer programs running on oneor more computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and or firmware would be well within the skill of one of skillin the art in light of this disclosure. In addition, those skilled inthe art will appreciate that the mechanisms of the subject matterdescribed herein are capable of being distributed as one or more programproducts in a variety of forms, and that an illustrative form of thesubject matter described herein applies regardless of the particulartype of signal bearing medium used to actually carry out thedistribution.

Instructions used to program logic to perform various disclosed aspectscan be stored within a memory in the system, such as dynamic randomaccess memory (DRAM), cache, flash memory, or other storage.Furthermore, the instructions can be distributed via a network or by wayof other computer readable media. Thus a machine-readable medium mayinclude any mechanism for storing or transmitting information in a formreadable by a machine (e.g., a computer), but is not limited to, floppydiskettes, optical disks, compact disc, read-only memory (CD-ROMs), andmagneto-optical disks, read-only memory (ROMs), random access memory(RAM), erasable programmable read-only memory (EPROM), electricallyerasable programmable read-only memory (EEPROM), magnetic or opticalcards, flash memory, or a tangible, machine-readable storage used in thetransmission of information over the Internet via electrical, optical,acoustical or other forms of propagated signals (e.g., carrier waves,infrared signals, digital signals, etc.). Accordingly, thenon-transitory computer-readable medium includes any type of tangiblemachine-readable medium suitable for storing or transmitting electronicinstructions or information in a form readable by a machine (e.g., acomputer).

As used in any aspect herein, the term “control circuit” may refer to,for example, hardwired circuitry, programmable circuitry (e.g., acomputer processor comprising one or more individual instructionprocessing cores, processing unit, processor, microcontroller,microcontroller unit, controller, digital signal processor (DSP),programmable logic device (PLD), programmable logic array (PLA), orfield programmable gate array (FPGA)), state machine circuitry, firmwarethat stores instructions executed by programmable circuitry, and anycombination thereof. The control circuit may, collectively orindividually, be embodied as circuitry that forms part of a largersystem, for example, an integrated circuit (IC), an application-specificintegrated circuit (ASIC), a system on-chip (SoC), desktop computers,laptop computers, tablet computers, servers, smart phones, etc.Accordingly, as used herein “control circuit” includes, but is notlimited to, electrical circuitry having at least one discrete electricalcircuit, electrical circuitry having at least one integrated circuit,electrical circuitry having at least one application specific integratedcircuit, electrical circuitry forming a general purpose computing deviceconfigured by a computer program (e.g., a general purpose computerconfigured by a computer program which at least partially carries outprocesses and/or devices described herein, or a microprocessorconfigured by a computer program which at least partially carries outprocesses and/or devices described herein), electrical circuitry forminga memory device (e.g., forms of random access memory), and/or electricalcircuitry forming a communications device (e.g., a modem, communicationsswitch, or optical-electrical equipment). Those having skill in the artwill recognize that the subject matter described herein may beimplemented in an analog or digital fashion or some combination thereof.

As used in any aspect herein, the term “logic” may refer to an app,software, firmware and/or circuitry configured to perform any of theaforementioned operations. Software may be embodied as a softwarepackage, code, instructions, instruction sets and/or data recorded onnon-transitory computer readable storage medium. Firmware may beembodied as code, instructions or instruction sets and/or data that arehard-coded (e.g., nonvolatile) in memory devices.

As used in any aspect herein, the terms “component,” “system,” “module”and the like can refer to a computer-related entity, either hardware, acombination of hardware and software, software, or software inexecution.

As used in any aspect herein, an “algorithm” refers to a self-consistentsequence of steps leading to a desired result, where a “step” refers toa manipulation of physical quantities and/or logic states which may,though need not necessarily, take the form of electrical or magneticsignals capable of being stored, transferred, combined, compared, andotherwise manipulated. It is common usage to refer to these signals asbits, values, elements, symbols, characters, terms, numbers, or thelike. These and similar terms may be associated with the appropriatephysical quantities and are merely convenient labels applied to thesequantities and/or states.

A network may include a packet switched network. The communicationdevices may be capable of communicating with each other using a selectedpacket switched network communications protocol. One examplecommunications protocol may include an Ethernet communications protocolwhich may be capable permitting communication using a TransmissionControl Protocol/Internet Protocol (TCP/IP). The Ethernet protocol maycomply or be compatible with the Ethernet standard published by theInstitute of Electrical and Electronics Engineers (IEEE) titled “IEEE802.3 Standard”, published in December, 2008 and/or later versions ofthis standard. Alternatively or additionally, the communication devicesmay be capable of communicating with each other using an X.25communications protocol. The X.25 communications protocol may comply orbe compatible with a standard promulgated by the InternationalTelecommunication Union-Telecommunication Standardization Sector(ITU-T). Alternatively or additionally, the communication devices may becapable of communicating with each other using a frame relaycommunications protocol. The frame relay communications protocol maycomply or be compatible with a standard promulgated by ConsultativeCommittee for International Telegraph and Telephone (CCITT) and/or theAmerican National Standards Institute (ANSI). Alternatively oradditionally, the transceivers may be capable of communicating with eachother using an Asynchronous Transfer Mode (ATM) communications protocol.The ATM communications protocol may comply or be compatible with an ATMstandard published by the ATM Forum titled “ATM-MPLS NetworkInterworking 2.0” published August 2001, and/or later versions of thisstandard. Of course, different and/or after-developedconnection-oriented network communication protocols are equallycontemplated herein.

Unless specifically stated otherwise as apparent from the foregoingdisclosure, it is appreciated that, throughout the foregoing disclosure,discussions using terms such as “processing,” “computing,”“calculating,” “determining,” “displaying,” or the like, refer to theaction and processes of a computer system, or similar electroniccomputing device, that manipulates and transforms data represented asphysical (electronic) quantities within the computer system's registersand memories into other data similarly represented as physicalquantities within the computer system memories or registers or othersuch information storage, transmission or display devices.

One or more components may be referred to herein as “configured to,”“configurable to,” “operable/operative to,” “adapted/adaptable,” “ableto,” “conformable/conformed to,” etc. Those skilled in the art willrecognize that “configured to” can generally encompass active-statecomponents and/or inactive-state components and/or standby-statecomponents, unless context requires otherwise.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” refers to the portion closest to the clinician andthe term “distal” refers to the portion located away from the clinician.It will be further appreciated that, for convenience and clarity,spatial terms such as “vertical”, “horizontal”, “up”, and “down” may beused herein with respect to the drawings. However, surgical instrumentsare used in many orientations and positions, and these terms are notintended to be limiting and/or absolute.

Those skilled in the art will recognize that, in general, terms usedherein, and especially in the appended claims (e.g., bodies of theappended claims) are generally intended as “open” terms (e.g., the term“including” should be interpreted as “including but not limited to,” theterm “having” should be interpreted as “having at least,” the term“includes” should be interpreted as “includes but is not limited to,”etc.). It will be further understood by those within the art that if aspecific number of an introduced claim recitation is intended, such anintent will be explicitly recited in the claim, and in the absence ofsuch recitation no such intent is present. For example, as an aid tounderstanding, the following appended claims may contain usage of theintroductory phrases “at least one” and “one or more” to introduce claimrecitations. However, the use of such phrases should not be construed toimply that the introduction of a claim recitation by the indefinitearticles “a” or “an” limits any particular claim containing suchintroduced claim recitation to claims containing only one suchrecitation, even when the same claim includes the introductory phrases“one or more” or “at least one” and indefinite articles such as “a” or“an” (e.g., “a” and/or “an” should typically be interpreted to mean “atleast one” or “one or more”); the same holds true for the use ofdefinite articles used to introduce claim recitations.

In addition, even if a specific number of an introduced claim recitationis explicitly recited, those skilled in the art will recognize that suchrecitation should typically be interpreted to mean at least the recitednumber (e.g., the bare recitation of “two recitations,” without othermodifiers, typically means at least two recitations, or two or morerecitations). Furthermore, in those instances where a conventionanalogous to “at least one of A, B, and C, etc.” is used, in generalsuch a construction is intended in the sense one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, and C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). In those instances where aconvention analogous to “at least one of A, B, or C, etc.” is used, ingeneral such a construction is intended in the sense one having skill inthe art would understand the convention (e.g., “a system having at leastone of A, B, or C” would include but not be limited to systems that haveA alone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together, etc.). It will be furtherunderstood by those within the art that typically a disjunctive wordand/or phrase presenting two or more alternative terms, whether in thedescription, claims, or drawings, should be understood to contemplatethe possibilities of including one of the terms, either of the terms, orboth terms unless context dictates otherwise. For example, the phrase “Aor B” will be typically understood to include the possibilities of “A”or “B” or “A and B.”

With respect to the appended claims, those skilled in the art willappreciate that recited operations therein may generally be performed inany order. Also, although various operational flow diagrams arepresented in a sequence(s), it should be understood that the variousoperations may be performed in other orders than those which areillustrated, or may be performed concurrently. Examples of suchalternate orderings may include overlapping, interleaved, interrupted,reordered, incremental, preparatory, supplemental, simultaneous,reverse, or other variant orderings, unless context dictates otherwise.Furthermore, terms like “responsive to,” “related to,” or otherpast-tense adjectives are generally not intended to exclude suchvariants, unless context dictates otherwise.

It is worthy to note that any reference to “one aspect,” “an aspect,”“an exemplification,” “one exemplification,” and the like means that aparticular feature, structure, or characteristic described in connectionwith the aspect is included in at least one aspect. Thus, appearances ofthe phrases “in one aspect,” “in an aspect,” “in an exemplification,”and “in one exemplification” in various places throughout thespecification are not necessarily all referring to the same aspect.Furthermore, the particular features, structures or characteristics maybe combined in any suitable manner in one or more aspects.

Any patent application, patent, non-patent publication, or otherdisclosure material referred to in this specification and/or listed inany Application Data Sheet is incorporated by reference herein, to theextent that the incorporated materials is not inconsistent herewith. Assuch, and to the extent necessary, the disclosure as explicitly setforth herein supersedes any conflicting material incorporated herein byreference. Any material, or portion thereof, that is said to beincorporated by reference herein, but which conflicts with existingdefinitions, statements, or other disclosure material set forth hereinwill only be incorporated to the extent that no conflict arises betweenthat incorporated material and the existing disclosure material.

In summary, numerous benefits have been described which result fromemploying the concepts described herein. The foregoing description ofthe one or more forms has been presented for purposes of illustrationand description. It is not intended to be exhaustive or limiting to theprecise form disclosed. Modifications or variations are possible inlight of the above teachings. The one or more forms were chosen anddescribed in order to illustrate principles and practical application tothereby enable one of ordinary skill in the art to utilize the variousforms and with various modifications as are suited to the particular usecontemplated. It is intended that the claims submitted herewith definethe overall scope.

What is claimed is:
 1. A surgical stapling instrument, comprising an endeffector, comprising: a first jaw; a second jaw movable relative to thefirst jaw between an open configuration and a closed configuration tograsp tissue between the first jaw and the second jaw; an anvil; and astaple cartridge comprising staples deployable into the tissue anddeformable by the anvil; and a control circuit configured to: determinetissue impedances at predetermined zones; detect an irregularity intissue distribution within the end effector based on the tissueimpedances; and adjust a closure parameter of the end effector inaccordance with the irregularity.
 2. The surgical stapling instrument ofclaim 1, wherein the end effector comprises sensing circuits at thepredetermined zones.
 3. The surgical stapling instrument of claim 2,wherein the predetermined zones are separated by insulating elements. 4.The surgical stapling instrument of claim 2, wherein the predeterminedzones comprise: an inner predetermined zone; an outer predeterminedzone; and an intermediate predetermined zone between the innerpredetermined zone and the outer predetermined zone.
 5. The surgicalstapling instrument of claim 4, wherein detecting the irregularity intissue distribution within the end effector comprises determining thatan average of the tissue impedances at the inner predetermined zone andthe outer predetermined zone is greater than the tissue impedance at theintermediate predetermined zone.
 6. The surgical stapling instrument ofclaim 5, wherein detecting the irregularity in tissue distributionwithin the end effector causes the control circuit to alert a user torelease and reposition the tissue grasped by the end effector.
 7. Thesurgical stapling instrument of claim 4, wherein detecting theirregularity in tissue distribution within the end effector comprises:determining that an average of the tissue impedances at the innerpredetermined zone and the outer predetermined zone is less than orequal to the tissue impedance at the intermediate predetermined zone;and determining that the tissue impedance of the inner predeterminedzone is greater than the tissue impedance of the outer predeterminedzone.
 8. The surgical stapling instrument of claim 7, further comprisinga motor configured to motivate the end effector to transition to theclosed configuration, wherein detecting the irregularity in tissuedistribution within the end effector causes the control circuit toreduce a speed of the motor.
 9. The surgical stapling instrument ofclaim 1, wherein the closure parameter is closure velocity.
 10. Thesurgical stapling instrument of claim 1, wherein the control circuit isconfigured to pass at least one therapeutic signal through tissue ateach of the predetermined zones to determine the tissue impedances. 11.A surgical stapling instrument for stapling a previously-stapled tissue,the surgical stapling instrument comprising: a shaft defining alongitudinal axis extending there through; and an end effector extendingfrom the shaft, comprising: a first jaw; a second jaw movable relativeto the first jaw between an open configuration and a closedconfiguration to grasp tissue between the first jaw and the second jaw;an anvil; a staple cartridge comprising staples deployable into thepreviously-stapled tissue and deformable by the anvil; and predeterminedzones between the anvil and the staple cartridge; a circuit configuredto: measure tissue impedances at the predetermined zones; compare themeasured tissue impedances to a predetermined tissue impedance signatureof the predetermined zones; and detect an irregularity in at least oneof position and orientation of the previously-stapled tissue within theend effector from the comparison.
 12. The surgical stapling instrumentof claim 11, wherein the end effector comprises sensing circuits at thepredetermined zones.
 13. The surgical stapling instrument of claim 12,wherein the predetermined zones are separated by insulating elements.14. The surgical stapling instrument of claim 13, wherein thepredetermined zones are circumferentially arranged about thelongitudinal axis.
 15. The surgical stapling instrument of claim 11,wherein detecting the irregularity causes the control circuit to alert auser.
 16. The surgical stapling instrument of claim 11, wherein thecontrol circuit is configured to pass at least one therapeutic signalthrough tissue at each of the predetermined zones to determine thetissue impedances.
 17. A surgical stapling instrument, comprising an endeffector, comprising: a first jaw; a second jaw movable relative to thefirst jaw between an open configuration and a closed configuration tograsp tissue between the first jaw and the second jaw; an anvil; astaple cartridge comprising staples deployable into the tissue anddeformable by the anvil; and predetermined zones between the anvil andthe staple cartridge; a control circuit configured to: determine anelectrical parameter of the tissue at each of the predetermined zones;detect an irregularity in tissue distribution within the end effectorbased on the determined electrical parameters; and adjust a closureparameter of the end effector in accordance with the irregularity. 18.The surgical stapling instrument of claim 17, wherein the end effectorcomprises sensing circuits at the predetermined zones.
 19. The surgicalstapling instrument of claim 18, wherein the predetermined zones areseparated by insulating elements.
 20. The surgical stapling instrumentof claim 17, wherein the closure parameter is closure velocity.